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A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992653
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma, Non Hodgkin
Interventions Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Drug: Prednisolone
Drug: Prednisone
Drug: Rituximab
Enrollment 85
Recruitment Details The study was conducted at 11 centers in 2 countries.
Pre-assignment Details A total of 85 participants were enrolled at 11 centers in the following countries: France (31 participants) and United States (54 participants). 3 participants did not receive any study treatment (2 had exclusionary lab values and 1 withdrew) meaning that the safety population consisted of 82 participants.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts. Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Period Title: Overall Study
Started 3 3 6 1 6 6 40 17
Completed 3 3 5 1 5 6 32 13
Not Completed 0 0 1 0 1 0 8 4
Reason Not Completed
Death             0             0             1             0             1             0             4             2
Lost to Follow-up             0             0             0             0             0             0             0             1
Study Completed             0             0             0             0             0             0             0             1
Disease Progression             0             0             0             0             0             0             4             0
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Total
Hide Arm/Group Description Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts. Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts. Total of all reporting groups
Overall Number of Baseline Participants 3 3 6 1 6 6 40 17 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants 1 participants 6 participants 6 participants 40 participants 17 participants 82 participants
67.3  (6.4) 65.0  (7.0) 67.3  (3.5) 68.0 [1]   (NA) 70.7  (4.5) 60.0  (14.3) 69.6  (7.2) 61.6  (14.6) 66.9  (9.9)
[1]
Due to there being only 1 participant in this group, the SD could not be estimated.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 1 participants 6 participants 6 participants 40 participants 17 participants 82 participants
Female
0
   0.0%
3
 100.0%
4
  66.7%
0
   0.0%
2
  33.3%
4
  66.7%
20
  50.0%
6
  35.3%
39
  47.6%
Male
3
 100.0%
0
   0.0%
2
  33.3%
1
 100.0%
4
  66.7%
2
  33.3%
20
  50.0%
11
  64.7%
43
  52.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 1 participants 6 participants 6 participants 40 participants 17 participants 82 participants
Not Hispanic or Latino 3 3 6 1 6 6 27 14 66
Not Stated 0 0 0 0 0 0 9 3 12
Unknown 0 0 0 0 0 0 4 0 4
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 1 participants 6 participants 6 participants 40 participants 17 participants 82 participants
Black or African American 0 0 0 0 1 0 0 1 2
Other 0 0 0 0 0 0 4 1 5
Unknown 0 0 0 0 0 0 3 0 3
White 3 3 6 1 5 6 33 15 72
1.Primary Outcome
Title Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population
Hide Description An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
Time Frame Baseline up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 2 3 5 0 4 4 40 17
Measure Type: Count of Participants
Unit of Measure: Participants
82
2
 100.0%
3
 100.0%
5
 100.0%
0
4
 100.0%
4
 100.0%
40
 100.0%
17
 100.0%
2.Primary Outcome
Title Number of Participants With Adverse Events in Non-DLBCL Population
Hide Description An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
Time Frame Baseline up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 1 0 1 1 2 2 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
82
1
 100.0%
0
1
 100.0%
1
 100.0%
2
 100.0%
2
 100.0%
0 0
3.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population
Hide Description All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD.
Time Frame Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 2 3 5 0 4 4 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  20.0%
0
1
  25.0%
0
   0.0%
0 0
4.Primary Outcome
Title Number of Participants With DLTs in Non-DLBCL Population
Hide Description All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD.
Time Frame Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 1 0 1 1 2 2 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
5.Secondary Outcome
Title Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Hide Description Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET.
Time Frame At the end of treatment (Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 2 3 5 0 4 4 40 17
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of Participants
Complete Response (CR)
50.0
(2.53 to 97.47)
100.0
(36.84 to 100.00)
100.0
(54.93 to 100.00)
75.0
(24.86 to 98.73)
100.0
(47.29 to 100.0)
75.0
(61.29 to 85.76)
76.5
(53.95 to 91.54)
Partial Response (PR)
50.0
(2.53 to 97.47)
0
(0.00 to 63.16)
0
(0.00 to 45.07)
0
(0.00 to 52.71)
0
(0.00 to 52.71)
15.0
(6.74 to 27.47)
11.8
(2.13 to 32.62)
6.Secondary Outcome
Title Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Hide Description Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET.
Time Frame At the end of treatment (Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 1 0 1 1 2 2 0 0
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of Participants
Complete Response (CR)
100.0
(5.00 to 100.00)
100.0
(5.00 to 100.00)
100.0
(5.00 to 100.00)
100.0
(22.36 to 100.00)
100.0
(22.36 to 100.0)
Partial Response (PR)
0
(0.00 to 95.00)
0
(0.00 to 95.00)
0
(0.00 to 95.00)
0
(0.00 to 77.64)
0
(0.00 to 77.64)
7.Secondary Outcome
Title Number of Participants With Anti-Polatuzumab Vedotin Antibodies
Hide Description The Anti-Drug Antibody (ADA) screening assay was optimized to tolerate drug interference and was able to detect 90 and 500 ng/mL of the positive control sample in the presence of 20 μg/mL of polatuzumab vedotin. Polatuzumab vedotin total antibody concentrations were determined for each ADA sample. Out of a total of 186 ADA samples that were measured for polatuzumab vedotin total antibody, 184 samples had levels less than 20 μg/mL. Polatuzumab vedotin total antibody concentrations ranged from <0.050 μg/mL to 52.1 μg/mL with a median concentration of 3.38 μg/mL.
Time Frame Baseline up to Month 9 (assessed prior to polatuzumab vedotin infusion [0 hour; Hr] on Day 2 [D2] of Cy 1 and 2, D1 of Cy 4, treatment completion/early termination [Month 6], and at 3 months post-treatment [Month 9]; cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 3 3 6 1 6 6 40 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Anti-Obinutuzumab Antibodies
Hide Description The ADA screening assay was optimized to tolerate drug interference and was able to detect 500 ng/mL of the ADA-positive control sample in the presence of 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations were determined for each ADA sample. Out of a total of 48 ADA samples that were measured for obinutuzumab, 9 samples had levels less than 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations in ADA samples ranged from 0.282 micrograms/mL to 522 micrograms/mL with a median concentration of 210 micrograms/mL. Therefore, it is possible that samples with obinutuzumab concentrations greater than 50 micrograms/mL might be false negative for ADA.
Time Frame Baseline up to Month 9 (assessed prior to obinutuzumab infusion [0 Hr] on D1 of Cy 1, 2, 4 and at 3 months post-treatment [Month 9]; cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 3 3 6 1 6 6 40 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin
Hide Description AUC information for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
Time Frame Pre-polatuzumab vedotin infusion (Hr 0), 30 minutes (min) post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 3 3 6 1 6 6 40 17
Mean (Standard Deviation)
Unit of Measure: ng day/mL
1300  (22) 1510  (354) 2600  (413) 4090 [1]   (NA) 1940  (154) 1850  (491) 1870  (527) 1940  (482)
[1]
Due to there being only 1 participant in this group, the SD could not be estimated.
10.Secondary Outcome
Title Maximum Concentration (Cmax) of Polatuzumab Vedotin
Hide Description Cmax for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
Time Frame Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 3 3 6 1 6 6 40 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
373  (147) 537  (184) 781  (72.6) 1400 [1]   (NA) 537  (59.1) 557  (114) 532  (163) 530  (138)
[1]
Due to there being only 1 participant in this group, the SD could not be estimated.
11.Secondary Outcome
Title Clearance (CL) of Polatuzumab Vedotin
Hide Description CL for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
Time Frame Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 3 3 6 1 6 6 40 17
Mean (Standard Deviation)
Unit of Measure: mL/day/kg
14.0  (0.370) 17.3  (4.16) 12.8  (2.05) 10.5 [1]   (NA) 13.2  (1.29) 18.7  (5.30) 18.9  (5.27) 17.7  (3.83)
[1]
Due to there being only 1 participant in this group, the SD could not be estimated.
12.Secondary Outcome
Title Terminal Half-Life (t1/2) of Polatuzumab Vedotin
Hide Description t1/2 for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
Time Frame Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 3 3 6 1 6 6 40 17
Mean (Standard Deviation)
Unit of Measure: days
5.03  (0.905) 4.85  (0.720) 4.79  (0.675) 4.42 [1]   (NA) 5.19  (0.430) 4.89  (0.526) 5.03  (0.621) 5.50  (0.795)
[1]
Due to there being only 1 participant in this group, the SD could not be estimated.
13.Secondary Outcome
Title Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin
Hide Description Vss for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.
Time Frame Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 3 3 6 1 6 6 40 17
Mean (Standard Deviation)
Unit of Measure: mL/kg
58.2  (9.92) 80.0  (9.97) 57.7  (7.95) 41.9 [1]   (NA) 67.9  (7.42) 87.5  (19.3) 96.5  (34.1) 99.3  (27.4)
[1]
Due to there being only 1 participant in this group, the SD could not be estimated.
14.Secondary Outcome
Title Plasma Levels of Cyclophosphamide
Hide Description Plasma levels of cyclophosphamide will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin.
Time Frame End of cyclophosphamide infusion (infusion time=1-24 Hr), 3 and 23 hours post end of cyclophosphamide infusion on D1 of Cy 1 and 3 (cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Plasma levels of cyclophosphamide were only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 0 0 0 0 0 0 40 17
Mean (Standard Deviation)
Unit of Measure: ug/mL
C1D1 0.5hr POSTDOSE Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 22 participants 13 participants
37.5  (24.4) 32.3  (7.64)
C1D1 3.5hr POSTDOSE Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 21 participants 13 participants
23.2  (2.38) 22.5  (3.69)
C1D1 23.5hr POSTDOSE Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 25 participants 14 participants
2.98  (1.39) 3.32  (1.50)
C3D1 0.5hr POSTDOSE Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 28 participants 15 participants
34.8  (6.14) 35.2  (13.4)
C3D1 3.5hr POSTDOSE Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 16 participants
24.2  (3.87) 22.5  (4.26)
C3D1 23.5hr POSTDOSE Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 19 participants 14 participants
3.17  (1.66) 3.16  (1.68)
15.Secondary Outcome
Title Plasma Levels of Doxorubicin
Hide Description Plasma levels of doxorubicin will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin.
Time Frame 2, 24 hours post end of doxorubicin infusion (infusion time=15 min) on D1 of Cy 1 and 3 (cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Plasma levels of doxorubicin were only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 0 0 0 0 0 0 40 17
Mean (Standard Deviation)
Unit of Measure: ug/mL
C1D1 2hr POSTDOSE Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 23 participants 11 participants
35.4  (13.6) 30.2  (6.82)
C1D1 24hr POSTDOSE Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 25 participants 12 participants
9.13  (2.51) 11.7  (11.6)
C3D1 2hr POSTDOSE Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 27 participants 16 participants
29.3  (10.9) 29.6  (10.8)
C3D1 24hr POSTDOSE Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 20 participants 14 participants
8.68  (2.05) 9.14  (2.12)
16.Secondary Outcome
Title Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score
Hide Description The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the participant can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Results are only being reported here up until the End of Treatment visit (duration of Study treatment).
Time Frame Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. TINAS was only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 0 0 0 0 0 0 40 17
Mean (Standard Deviation)
Unit of Measure: Score of a Questionnaire
Baseline Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants
0 [1]   (NA) 0.32  (0.45)
Week 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 3 participants
0  (0) 0.91  (0.92)
Week 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 4 participants 5 participants
0.02  (0.04) 0.07  (0.16)
Week 3 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 5 participants
0.06  (0.10) 0.22  (0.44)
Week 4 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 6 participants
0.18  (0.36) 0.26  (0.63)
Week 5 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 6 participants
0.16  (0.32) 0.17  (0.41)
Week 6 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 5 participants
0.16  (0.32) 0.25  (0.57)
Week 7 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants 5 participants
0.14  (0.28) 0.35  (0.77)
Week 8 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 6 participants 8 participants
0.17  (0.37) 0.31  (0.59)
Week 9 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 8 participants
0.25  (0.47) 0.38  (0.61)
Week 10 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants 7 participants
0.30  (0.41) 0.53  (0.71)
Week 11 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants 7 participants
0.26  (0.35) 0.39  (0.73)
Week 12 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants 7 participants
0.30  (0.43) 0.65  (1.02)
Week 13 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants 8 participants
0.25  (0.32) 0.78  (1.34)
Week 14 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 8 participants 8 participants
0.49  (0.86) 0.62  (1.05)
Week 15 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 8 participants 8 participants
0.48  (0.86) 0.70  (1.28)
Week 16 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 8 participants
0.66  (0.94) 1.12  (1.61)
Week 17 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 7 participants
0.25  (0.52) 0.91  (1.44)
Week 18 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
0.64 [1]   (NA)
Week 19 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
0.45 [1]   (NA)
Week 20 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
Week 21 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
Week 22 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
0.09 [1]   (NA)
[1]
Due to there being only 1 participant in this group, the SD could not be estimated.
17.Secondary Outcome
Title Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score
Hide Description The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the patient can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Additionally, a single item that asks patients to rate when numbness and tingling was at the worst will be used to predict the onset of peripheral neuropathy. The measure takes less than 5 minutes to complete. Results are only being reported here up until the End of Treatment visit (duration of Study treatment).
Time Frame Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. TINAS was only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 0 0 0 0 0 0 40 17
Mean (Standard Deviation)
Unit of Measure: Score of a Questionnaire
Baseline Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants
0 [1]   (NA) 0  (0)
Week 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 3 participants
0  (0) 1  (1.73)
Week 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 4 participants 5 participants
0.25  (0.50) 0  (0)
Week 3 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 5 participants
0.33  (0.58) 0.40  (0.89)
Week 4 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 6 participants
0.40  (0.55) 0.50  (1.22)
Week 5 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 6 participants
0.40  (0.55) 0.17  (0.41)
Week 6 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 5 participants
0.40  (0.55) 0.40  (0.89)
Week 7 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants 5 participants
0.29  (0.49) 0.60  (1.34)
Week 8 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 6 participants 8 participants
0.33  (0.52) 0.25  (0.71)
Week 9 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 8 participants
0.40  (0.55) 0.50  (1.07)
Week 10 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants 7 participants
0.86  (1.21) 1.14  (1.46)
Week 11 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants 7 participants
0.86  (1.21) 0.57  (1.13)
Week 12 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants 7 participants
1.14  (1.21) 0.71  (1.25)
Week 13 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 7 participants 8 participants
0.86  (1.21) 1.12  (1.81)
Week 14 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 8 participants 8 participants
1.12  (1.73) 0.88  (1.36)
Week 15 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 8 participants 8 participants
1.12  (1.73) 0.75  (1.16)
Week 16 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 8 participants
1.56  (2.07) 1.50  (1.69)
Week 17 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 7 participants
0.40  (0.55) 1.14  (1.46)
Week 18 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
2 [1]   (NA)
Week 19 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
2 [1]   (NA)
Week 20 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
Week 21 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
Week 22 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
1 [1]   (NA)
[1]
Due to there being only 1 participant in this group, the SD could not be estimated.
18.Secondary Outcome
Title Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Hide Description Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment.
Time Frame Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 2 3 5 0 4 4 40 17
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(14.03 to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(27.93 to NA)
NA [1] 
(NA to NA)
[1]
Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
19.Secondary Outcome
Title Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Hide Description Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment.
Time Frame Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 1 0 1 1 2 2 0 0
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
4.11 [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
20.Secondary Outcome
Title Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Hide Description Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1.
Time Frame Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 2 3 5 0 4 4 40 17
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(17.02 to NA)
NA [1] 
(7.79 to NA)
NA [1] 
(NA to NA)
NA [1] 
(30.62 to NA)
NA [1] 
(NA to NA)
[1]
Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
21.Secondary Outcome
Title Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Hide Description Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1.
Time Frame Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 1 0 1 1 2 2 0 0
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
6.87 [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
22.Secondary Outcome
Title Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
Hide Description Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization.
Time Frame Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 2 3 5 0 4 4 40 17
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(17.02 to NA)
NA [1] 
(3.42 to NA)
NA [1] 
(5.88 to NA)
35.45 [1] 
(28.32 to NA)
NA [1] 
(NA to NA)
[1]
Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
23.Secondary Outcome
Title Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
Hide Description Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization.
Time Frame Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 1 0 1 1 2 2 0 0
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
6.87 [1] 
(NA to NA)
6.70 [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
24.Secondary Outcome
Title Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population
Hide Description Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 2 3 5 0 4 4 40 17
Mean (Standard Deviation)
Unit of Measure: Percentage
100.70  (0.99) 99.97  (0.55) 96.04  (4.81) 99.35  (3.19) 99.95  (0.75) 96.71  (6.99) 98.92  (3.74)
25.Secondary Outcome
Title Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population
Hide Description Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 1 0 1 1 2 2 0 0
Mean (Standard Deviation)
Unit of Measure: Percentage
100.00 [1]   (NA) 100.94 [1]   (NA) 132.22 [1]   (NA) 99.72  (0.06) 100.17  (0.14)
[1]
Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
26.Secondary Outcome
Title Overall Survival for DLBCL Population
Hide Description The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive.
Time Frame Screening up to death due to any cause (up to approximately 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 2 3 5 0 4 4 40 17
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(7.79 to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
27.Secondary Outcome
Title Overall Survival for Non-DLBCL Population
Hide Description The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive.
Time Frame Screening up to death due to any cause (up to approximately 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description:
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.
Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Number of Participants Analyzed 1 0 1 1 2 2 0 0
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
15.24 [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.
Time Frame 5 years
Adverse Event Reporting Description The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
 
Arm/Group Title Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Hide Arm/Group Description Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts. Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
All-Cause Mortality
Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      1/6 (16.67%)      0/1 (0.00%)      1/6 (16.67%)      0/6 (0.00%)      4/40 (10.00%)      2/17 (11.76%)    
Hide Serious Adverse Events
Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      1/3 (33.33%)      4/6 (66.67%)      0/1 (0.00%)      1/6 (16.67%)      3/6 (50.00%)      15/40 (37.50%)      6/17 (35.29%)    
Blood and lymphatic system disorders                 
FEBRILE NEUTROPENIA  1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  3 3/40 (7.50%)  4 4/17 (23.53%)  4
NEUTROPENIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  3 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 1/17 (5.88%)  1
THROMBOCYTOPENIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
Cardiac disorders                 
ATRIAL FIBRILLATION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 2/40 (5.00%)  2 0/17 (0.00%)  0
CORONARY ARTERY DISEASE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
SUPRAVENTRICULAR TACHYCARDIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
Gastrointestinal disorders                 
DIARRHOEA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
DYSPHAGIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
VOMITING  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
General disorders                 
ASTHENIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
Infections and infestations                 
CLOSTRIDIUM DIFFICILE INFECTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 0/40 (0.00%)  0 0/17 (0.00%)  0
ESCHERICHIA URINARY TRACT INFECTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
LUNG INFECTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
ORAL FUNGAL INFECTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
PNEUMONIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 1/17 (5.88%)  1
SEPSIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
SEPTIC SHOCK  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
Injury, poisoning and procedural complications                 
FEMUR FRACTURE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
INFUSION RELATED REACTION  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
PELVIC FRACTURE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
Investigations                 
INFLUENZA A VIRUS TEST POSITIVE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/40 (5.00%)  2 0/17 (0.00%)  0
Metabolism and nutrition disorders                 
HYPERGLYCAEMIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
HYPONATRAEMIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
MALNUTRITION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
ARTHRITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
RHEUMATOID ARTHRITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
Nervous system disorders                 
SYNCOPE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/40 (2.50%)  1 0/17 (0.00%)  0
Psychiatric disorders                 
ANXIETY  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
MENTAL STATUS CHANGES  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
Renal and urinary disorders                 
ACUTE KIDNEY INJURY  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
CHYLOTHORAX  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
PULMONARY EMBOLISM  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Polatuzumab Vedotin (1.0mg) + R-CHP Polatuzumab Vedotin (1.4mg) + R-CHP Polatuzumab Vedotin (1.8mg) + R-CHP Polatuzumab Vedotin (2.4mg) + R-CHP Polatuzumab Vedotin (1.4mg) + G-CHP Polatuzumab Vedotin (1.8mg) + G-CHP Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      1/1 (100.00%)      6/6 (100.00%)      6/6 (100.00%)      40/40 (100.00%)      17/17 (100.00%)    
Blood and lymphatic system disorders                 
ANAEMIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 3/6 (50.00%)  4 2/6 (33.33%)  5 14/40 (35.00%)  24 3/17 (17.65%)  7
FEBRILE NEUTROPENIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 3/40 (7.50%)  3 1/17 (5.88%)  1
LEUKOCYTOSIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 6/40 (15.00%)  9 3/17 (17.65%)  4
LEUKOPENIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 7/40 (17.50%)  16 2/17 (11.76%)  2
NEUTROPENIA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 4/6 (66.67%)  8 0/1 (0.00%)  0 3/6 (50.00%)  3 5/6 (83.33%)  5 13/40 (32.50%)  22 6/17 (35.29%)  9
PANCYTOPENIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 0/40 (0.00%)  0 1/17 (5.88%)  1
THROMBOCYTOPENIA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 1/6 (16.67%)  3 1/6 (16.67%)  2 6/40 (15.00%)  16 6/17 (35.29%)  6
Cardiac disorders                 
PALPITATIONS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
SUPRAVENTRICULAR TACHYCARDIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
TACHYCARDIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 2/40 (5.00%)  2 2/17 (11.76%)  3
Ear and labyrinth disorders                 
CERUMEN IMPACTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
EAR DISCOMFORT  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
EAR PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
EXCESSIVE CERUMEN PRODUCTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
HYPOACUSIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
MIDDLE EAR EFFUSION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
Eye disorders                 
AMBLYOPIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
CATARACT  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
CONJUNCTIVAL HYPERAEMIA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
CONJUNCTIVAL IRRITATION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
DIPLOPIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
EYE IRRITATION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
LACRIMATION INCREASED  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
Gastrointestinal disorders                 
ABDOMINAL PAIN  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/40 (5.00%)  2 2/17 (11.76%)  2
ABDOMINAL PAIN UPPER  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 3/40 (7.50%)  4 0/17 (0.00%)  0
COLITIS MICROSCOPIC  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
CONSTIPATION  1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 1/1 (100.00%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2 11/40 (27.50%)  14 5/17 (29.41%)  5
DIARRHOEA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 5/6 (83.33%)  7 1/1 (100.00%)  1 2/6 (33.33%)  4 2/6 (33.33%)  2 17/40 (42.50%)  25 11/17 (64.71%)  14
DRY MOUTH  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/40 (2.50%)  1 1/17 (5.88%)  1
DYSPEPSIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/1 (100.00%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 2/40 (5.00%)  2 1/17 (5.88%)  2
DYSPHAGIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 3/40 (7.50%)  3 1/17 (5.88%)  1
ERUCTATION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
FLATULENCE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
GASTROINTESTINAL MOTILITY DISORDER  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 2/17 (11.76%)  2
HAEMATOCHEZIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
HAEMORRHOIDS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
HYPERCHLORHYDRIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
NAUSEA  1  1/3 (33.33%)  1 3/3 (100.00%)  5 4/6 (66.67%)  7 1/1 (100.00%)  1 3/6 (50.00%)  3 3/6 (50.00%)  3 16/40 (40.00%)  26 10/17 (58.82%)  12
ORAL PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
SMALL INTESTINAL OBSTRUCTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
STOMATITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/40 (2.50%)  1 1/17 (5.88%)  1
VOMITING  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 6/40 (15.00%)  8 3/17 (17.65%)  4
General disorders                 
ASTHENIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 9/40 (22.50%)  12 1/17 (5.88%)  4
CATHETER SITE PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
CHEST DISCOMFORT  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
CHEST PAIN  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 3/40 (7.50%)  3 1/17 (5.88%)  1
CHILLS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 4/40 (10.00%)  4 3/17 (17.65%)  3
DEVICE RELATED THROMBOSIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
FACE OEDEMA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  2
FATIGUE  1  2/3 (66.67%)  2 3/3 (100.00%)  4 3/6 (50.00%)  3 1/1 (100.00%)  1 1/6 (16.67%)  1 4/6 (66.67%)  4 16/40 (40.00%)  29 11/17 (64.71%)  16
FEELING HOT  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
GAIT DISTURBANCE  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
ILL-DEFINED DISORDER  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
MUCOSAL INFLAMMATION  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/40 (5.00%)  3 0/17 (0.00%)  0
NON-CARDIAC CHEST PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
OEDEMA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/1 (100.00%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
OEDEMA PERIPHERAL  1  0/3 (0.00%)  0 1/3 (33.33%)  2 1/6 (16.67%)  1 0/1 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2 4/40 (10.00%)  4 3/17 (17.65%)  3
PAIN  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 4/40 (10.00%)  5 1/17 (5.88%)  1
PERIPHERAL SWELLING  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/40 (2.50%)  1 0/17 (0.00%)  0
PYREXIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  3 9/40 (22.50%)  11 4/17 (23.53%)  4
Hepatobiliary disorders                 
HEPATIC STEATOSIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
Immune system disorders                 
SEASONAL ALLERGY  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
Infections and infestations                 
BACTERAEMIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
BRONCHITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 7/40 (17.50%)  10 2/17 (11.76%)  2
CANDIDA INFECTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 3/40 (7.50%)  3 0/17 (0.00%)  0
CONJUNCTIVITIS VIRAL  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
CYSTITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
ESCHERICHIA URINARY TRACT INFECTION  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
FOLLICULITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
FUNGAL INFECTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
NASOPHARYNGITIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
OPHTHALMIC HERPES ZOSTER  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
ORAL CANDIDIASIS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
OTITIS MEDIA  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
PNEUMONIA  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 1/17 (5.88%)  1
RASH PUSTULAR  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/40 (0.00%)  0 0/17 (0.00%)  0
SINUSITIS  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 0/40 (0.00%)  0 2/17 (11.76%)  3
SUBCUTANEOUS ABSCESS  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/40 (2.50%)  1 0/17 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/40 (0.00%)  0 0/17 (0.00%)  0
URINARY TRACT INFECTION  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/1 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 4/40 (10.00%)  4 0/17 (0.00%)  0