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Trial record 64 of 791 for:    LENALIDOMIDE AND cells

Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell 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: NCT02142049
Recruitment Status : Completed
First Posted : May 20, 2014
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diffuse Large B Cell Lymphoma Relapsed
Diffuse Large B Cell Lymphoma Refractory
Interventions Drug: Ibrutinib
Drug: DA-EPOCH-R
Drug: Lenalidomide
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part 1: Dose Level 1 Part 1: Dose Level 2 Part 1: Dose Level 3 Part 1: Dose Level 4 Part 2: RP2D
Hide Arm/Group Description

Ibrutinib 560 mg PO + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Period Title: Overall Study
Started 3 3 3 6 20
Completed 3 3 3 6 20
Not Completed 0 0 0 0 0
Arm/Group Title Part 1: Dose Level 1 Part 1: Dose Level 2 Part 1: Dose Level 3 Part 1: Dose Level 4 Part 2: RP2D Total
Hide Arm/Group Description

Ibrutinib 560 mg PO + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 6 20 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 6 participants 20 participants 35 participants
<=18 years 0 0 0 0 0 0
Between 18 and 65 years 1 3 1 6 11 22
>=65 years 2 0 2 0 9 13
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 6 participants 20 participants 35 participants
69
(54 to 89)
58
(41 to 61)
67
(58 to 68)
55
(38 to 61)
59
(28 to 79)
58
(28 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 6 participants 20 participants 35 participants
Female
0
   0.0%
1
  33.3%
0
   0.0%
1
  16.7%
7
  35.0%
9
  25.7%
Male
3
 100.0%
2
  66.7%
3
 100.0%
5
  83.3%
13
  65.0%
26
  74.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 6 participants 20 participants 35 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
3
 100.0%
3
 100.0%
6
 100.0%
17
  85.0%
32
  91.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  15.0%
3
   8.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 6 participants 20 participants 35 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   5.0%
2
   5.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  10.0%
2
   5.7%
White
3
 100.0%
2
  66.7%
3
 100.0%
6
 100.0%
15
  75.0%
29
  82.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  10.0%
2
   5.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 3 participants 6 participants 20 participants 35 participants
3 3 3 6 20 35
1.Primary Outcome
Title Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability
Hide Description Part-1: To determine the maximum tolerated dose (MTD) of the combination of ibrutinib and lenalidomide with dose adjusted EPOCH-R
Time Frame 1 year after last subjects received the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1: Dose Level 1 Part 1: Dose Level 2 Part 1: Dose Level 3 Part 1: Dose Level 4 Part 1: All Treated
Hide Arm/Group Description:

Ibrutinib 560 mg PO + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 0,15, 20, and 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Overall Number of Participants Analyzed 3 3 3 6 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
   6.7%
2.Primary Outcome
Title Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy-ORR
Hide Description Part 2 - Overall Response rate will be defined as the proportion of subjects who achieve either a Complete Response or a Partial Response according to the international Working Group Response Criteria for NHL as assessed by investigator.
Time Frame 1 year after last subjects received the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated at RP2D ABC Subjects Treated at RP2D
Hide Arm/Group Description:

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Note: There are only 17 samples available for DLBCL subtype test per GEP. Among of them 14 subjects were identified with ABC.

Overall Number of Participants Analyzed 26 14
Measure Type: Count of Participants
Unit of Measure: Participants
16
  61.5%
9
  64.3%
3.Secondary Outcome
Title Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy
Hide Description Part-1: Overall Response rate (ORR) will defined as the proportion of subjects who achieve either a CR or a PR according to the international Working Group Response Criteria for NHL as assessed by investigator.
Time Frame 1 year after last subjects received the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1: Dose Level 1 Part 1: Dose Level 2 Part 1: Dose Level 3 Part 1: Dose Level 4 Part 1: All Treated
Hide Arm/Group Description:

Ibrutinib 560 mg PO + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 0,15, 20, and 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Overall Number of Participants Analyzed 3 3 3 6 15
Measure Type: Count of Participants
Unit of Measure: Participants
1
  33.3%
2
  66.7%
0
   0.0%
3
  50.0%
6
  40.0%
4.Secondary Outcome
Title Number of Subjects With Adverse Events as a Measure of Safety and Tolerability
Hide Description Part 2: The frequency (number and percentage) of treatment-emergent adverse events will be reported.
Time Frame 1 year after last subjects received the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated at RP2D ABC Subjects Treated at RP2D
Hide Arm/Group Description:

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Note: There are only 17 samples available for DLBCL subtype test per GEP. Among of them 14 subjects were identified with ABC.

Overall Number of Participants Analyzed 26 14
Measure Type: Count of Participants
Unit of Measure: Participants
26
 100.0%
14
 100.0%
5.Secondary Outcome
Title Progression Free Survival (PFS) and Overall Survival (OS) as a Measure of Efficacy
Hide Description Part 2: PFS will be measured as time from first study drug administration to disease progression or death from any cause. OS will be measured from the time of first study drug administration until the date of death using Kaplan-Meier methodology.
Time Frame From initial dose date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose, up to 36 months at the most.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated at RP2D ABC Subjects Treated at RP2D
Hide Arm/Group Description:

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Note: There are only 17 samples available for DLBCL subtype test per GEP. Among them 14 subjects were identified with ABC.

Overall Number of Participants Analyzed 26 14
Median (Full Range)
Unit of Measure: Months
Progression Free Survival (PFS)
4.86
(0.03 to 12.45)
4.86
(0.03 to 9.69)
Overall Survival (OS)
15.84
(0.26 to 28.22)
15.84
(0.26 to 28.22)
6.Secondary Outcome
Title Duration of Response (DOR)
Hide Description Part 2: DOR will be measured from the time by which the measurement criteria are met for CR or PR until the first date by which recurrent or progressive disease is objectively documented.
Time Frame From initial response date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects Treated at RP2D Who Achieved Overall Response ABC Subjects Treated at RP2D Who Achieved Overall Response
Hide Arm/Group Description:

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Note: There are only 17 samples available for DLBCL subtype test per GEP. Among of them 14 subjects were identified with ABC.

Overall Number of Participants Analyzed 16 9
Median (Full Range)
Unit of Measure: Months
3.94
(0.03 to 10.48)
4.09
(0.03 to 7.69)
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part 1: Dose Level 1 Part 1: Dose Level 2 Part 1: Dose Level 3 Part 1: Dose Level 4 All Subjects Treated at RP2D
Hide Arm/Group Description

Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 0 (PO)

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 15 (PO)

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 20 (PO)

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg PO + DA-EPOCH-R + lenalidomide 25 mg (PO)

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R

DA-EPOCH-R: Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

All-Cause Mortality
Part 1: Dose Level 1 Part 1: Dose Level 2 Part 1: Dose Level 3 Part 1: Dose Level 4 All Subjects Treated at RP2D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      5/6 (83.33%)      3/26 (11.54%)    
Show Serious Adverse Events Hide Serious Adverse Events
Part 1: Dose Level 1 Part 1: Dose Level 2 Part 1: Dose Level 3 Part 1: Dose Level 4 All Subjects Treated at RP2D
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%)      3/3 (100.00%)      5/6 (83.33%)      19/26 (73.08%)    
Blood and lymphatic system disorders           
Febrile neutropenia * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 6/26 (23.08%)  6
Anaemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  2 2/26 (7.69%)  2
Thrombocytopenia * 1  1/3 (33.33%)  3 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/26 (3.85%)  1
Cardiac disorders           
Atrial fibrillation * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 1/26 (3.85%)  1
Gastrointestinal disorders           
Abdominal pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Colitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/26 (7.69%)  2
Gastrointestinal haemorrhage * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Neutropenic colitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Vomiting * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/26 (3.85%)  1
General disorders           
Death * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Pyrexia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 3/26 (11.54%)  3
Infections and infestations           
Abdominal wall abscess * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Clostridium difficile infection * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Enterococcal sepsis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Pneumonia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 2/26 (7.69%)  3
Pneumococcal sepsis * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Septic shock * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Injury, poisoning and procedural complications           
Fall * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Metabolism and nutrition disorders           
Dehydration * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Hypokalaemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 1/26 (3.85%)  2
Nervous system disorders           
Syncope * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 2/26 (7.69%)  2
Renal and urinary disorders           
Acute kidney injury * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Hydronephrosis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Urinary tract obstruction * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders           
Diffuse alveolar damage * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Vascular disorders           
Hypotension * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  2 2/26 (7.69%)  3
Orthostatic hypotension * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
1
Term from vocabulary, MedDRA (19.1)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: Dose Level 1 Part 1: Dose Level 2 Part 1: Dose Level 3 Part 1: Dose Level 4 All Subjects Treated at RP2D
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%)      3/3 (100.00%)      6/6 (100.00%)      26/26 (100.00%)    
Blood and lymphatic system disorders           
Anaemia * 1  3/3 (100.00%)  11 3/3 (100.00%)  29 2/3 (66.67%)  22 4/6 (66.67%)  16 12/26 (46.15%)  42
Thrombocytopenia * 1  3/3 (100.00%)  12 1/3 (33.33%)  4 1/3 (33.33%)  7 3/6 (50.00%)  6 12/26 (46.15%)  28
Leukopenia * 1  1/3 (33.33%)  1 2/3 (66.67%)  4 1/3 (33.33%)  5 2/6 (33.33%)  5 4/26 (15.38%)  11
Neutropenia * 1  2/3 (66.67%)  5 1/3 (33.33%)  1 2/3 (66.67%)  6 1/6 (16.67%)  1 6/26 (23.08%)  11
Febrile neutropenia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/6 (66.67%)  4 5/26 (19.23%)  5
Lymphopenia * 1  0/3 (0.00%)  0 2/3 (66.67%)  13 0/3 (0.00%)  0 0/6 (0.00%)  0 1/26 (3.85%)  1
Increased tendency to bruise * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Leukocytosis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Pancytopenia * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/26 (3.85%)  1
Cardiac disorders           
Sinus tachycardia * 1  0/3 (0.00%)  0 3/3 (100.00%)  9 1/3 (33.33%)  3 3/6 (50.00%)  3 6/26 (23.08%)  6
Palpitations * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Atrial fibrillation * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/26 (7.69%)  2
Tachycardia * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Angina pectoris * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/26 (3.85%)  1
Atrial flutter * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Mitral valve incompetence * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Congenital, familial and genetic disorders           
Atrial septal defect * 1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Ear and labyrinth disorders           
Ear discomfort * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Eye disorders           
Vision blurred * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Gastrointestinal disorders           
Nausea * 1  1/3 (33.33%)  4 3/3 (100.00%)  10 1/3 (33.33%)  6 5/6 (83.33%)  7 12/26 (46.15%)  21
Constipation * 1  1/3 (33.33%)  3 3/3 (100.00%)  11 2/3 (66.67%)  4 3/6 (50.00%)  5 11/26 (42.31%)  17
Diarrhoea * 1  0/3 (0.00%)  0 2/3 (66.67%)  3 2/3 (66.67%)  8 5/6 (83.33%)  9 15/26 (57.69%)  24
Abdominal pain * 1  1/3 (33.33%)  1 1/3 (33.33%)  3 1/3 (33.33%)  3 2/6 (33.33%)  5 4/26 (15.38%)  7
Abdominal distension * 1  1/3 (33.33%)  1 1/3 (33.33%)  2 1/3 (33.33%)  2 1/6 (16.67%)  2 2/26 (7.69%)  3
Gastrooesophageal reflux disease * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 2/26 (7.69%)  2
Dry mouth * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 2/26 (7.69%)  2
Dysphagia * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/26 (7.69%)  3
Anal incontinence * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Aphthous ulcer * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Cheilitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Dyspepsia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 3/26 (11.54%)  4
Faeces discoloured * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Flatulence * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/26 (3.85%)  1
Gastric polyps * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Gastritis * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Ileus * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Odynophagia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Oesophagitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Stomatitis * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/26 (11.54%)  3
Vomiting * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 4/26 (15.38%)  9
General disorders           
Fatigue * 1  2/3 (66.67%)  3 3/3 (100.00%)  17 1/3 (33.33%)  5 5/6 (83.33%)  6 13/26 (50.00%)  16
Oedema peripheral * 1  1/3 (33.33%)  1 3/3 (100.00%)  8 3/3 (100.00%)  4 2/6 (33.33%)  3 7/26 (26.92%)  8
Pyrexia * 1  0/3 (0.00%)  0 2/3 (66.67%)  4 0/3 (0.00%)  0 2/6 (33.33%)  3 5/26 (19.23%)  6
Non-cardiac chest pain * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 2/6 (33.33%)  3 3/26 (11.54%)  4
Pain * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 1/3 (33.33%)  1 0/6 (0.00%)  0 2/26 (7.69%)  2
Asthenia * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 3/26 (11.54%)  3
Catheter site pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  3 0/6 (0.00%)  0 0/26 (0.00%)  0
Chills * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 3/26 (11.54%)  3
Gait disturbance * 1  0/3 (0.00%)  0 1/3 (33.33%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Injection site haematoma * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Oedema * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Peripheral swelling * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Immune system disorders           
Hypogammaglobulinaemia * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Infections and infestations           
Fungal skin infection * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Kidney infection * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Oral candidiasis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 0/6 (0.00%)  0 0/26 (0.00%)  0
Sinusitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Upper respiratory tract infection * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Urinary tract infection * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  4 2/26 (7.69%)  5
Urosepsis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Injury, poisoning and procedural complications           
Laceration * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/3 (66.67%)  2 0/6 (0.00%)  0 0/26 (0.00%)  0
Allergic transfusion reaction * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Excoriation * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Fall * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 3/26 (11.54%)  4
Incision site pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Procedural pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Skin abrasion * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Wound haemorrhage * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Investigations           
Weight decreased * 1  1/3 (33.33%)  3 2/3 (66.67%)  8 1/3 (33.33%)  2 1/6 (16.67%)  1 2/26 (7.69%)  2
Electrocardiogram QT prolonged * 1  1/3 (33.33%)  2 1/3 (33.33%)  2 0/3 (0.00%)  0 1/6 (16.67%)  1 2/26 (7.69%)  2
Platelet count decreased * 1  0/3 (0.00%)  0 1/3 (33.33%)  19 1/3 (33.33%)  6 1/6 (16.67%)  2 4/26 (15.38%)  6
Weight increased * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/26 (3.85%)  1
Blood creatinine increased * 1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Blood lactate dehydrogenase increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Immunoglobulins decreased * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Lymphocyte count decreased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  3 1/26 (3.85%)  3
Neutrophil count decreased * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/26 (3.85%)  1
Urine output decreased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Metabolism and nutrition disorders           
Hypokalaemia * 1  1/3 (33.33%)  1 2/3 (66.67%)  7 2/3 (66.67%)  7 2/6 (33.33%)  20 11/26 (42.31%)  42
Decreased appetite * 1  1/3 (33.33%)  3 2/3 (66.67%)  3 1/3 (33.33%)  3 2/6 (33.33%)  3 5/26 (19.23%)  6
Dehydration * 1  0/3 (0.00%)  0 1/3 (33.33%)  3 1/3 (33.33%)  1 3/6 (50.00%)  3 4/26 (15.38%)  4
Hypoalbuminaemia * 1  1/3 (33.33%)  1 2/3 (66.67%)  3 1/3 (33.33%)  8 1/6 (16.67%)  2 3/26 (11.54%)  6
Hyperglycaemia * 1  1/3 (33.33%)  7 1/3 (33.33%)  15 1/3 (33.33%)  13 1/6 (16.67%)  1 4/26 (15.38%)  16
Hypomagnesaemia * 1  1/3 (33.33%)  3 0/3 (0.00%)  0 1/3 (33.33%)  1 2/6 (33.33%)  3 5/26 (19.23%)  9
Hyponatraemia * 1  1/3 (33.33%)  2 1/3 (33.33%)  1 1/3 (33.33%)  6 1/6 (16.67%)  2 5/26 (19.23%)  6
Fluid overload * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/26 (3.85%)  1
Hyperuricaemia * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 3/26 (11.54%)  3
Hypervolaemia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Hyperchloraemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Hypernatraemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Hyperphosphataemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Hypocalcaemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  4 3/26 (11.54%)  6
Hypoglycaemia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Hypophosphataemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  2 4/26 (15.38%)  5
Magnesium deficiency * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Malnutrition * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Metabolic acidosis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Vitamin D deficiency * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back pain * 1  1/3 (33.33%)  6 1/3 (33.33%)  3 1/3 (33.33%)  1 2/6 (33.33%)  2 6/26 (23.08%)  6
Muscular weakness * 1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Myalgia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 3/26 (11.54%)  3
Pain in extremity * 1  1/3 (33.33%)  4 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 3/26 (11.54%)  3
Arthralgia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 4/26 (15.38%)  4
Groin pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Muscle twitching * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Musculoskeletal pain * 1  0/3 (0.00%)  0 1/3 (33.33%)  4 0/3 (0.00%)  0 0/6 (0.00%)  0 1/26 (3.85%)  1
Musculoskeletal stiffness * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Pain in jaw * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Nervous system disorders           
Dizziness * 1  1/3 (33.33%)  1 3/3 (100.00%)  6 2/3 (66.67%)  2 3/6 (50.00%)  6 8/26 (30.77%)  16
Peripheral sensory neuropathy * 1  1/3 (33.33%)  1 2/3 (66.67%)  6 1/3 (33.33%)  2 2/6 (33.33%)  2 6/26 (23.08%)  7
Headache * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 2/6 (33.33%)  2 6/26 (23.08%)  6
Hypoaesthesia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 3/26 (11.54%)  3
Dysgeusia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 4/26 (15.38%)  4
Peripheral motor neuropathy * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/26 (7.69%)  2
Somnolence * 1  1/3 (33.33%)  1 1/3 (33.33%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Tremor * 1  0/3 (0.00%)  0 2/3 (66.67%)  5 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Depressed level of consciousness * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Dysarthria * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Lethargy * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Peroneal nerve palsy * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Post herpetic neuralgia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Syncope * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Psychiatric disorders           
Insomnia * 1  1/3 (33.33%)  1 2/3 (66.67%)  5 2/3 (66.67%)  4 1/6 (16.67%)  2 5/26 (19.23%)  6
Anxiety * 1  1/3 (33.33%)  1 1/3 (33.33%)  3 1/3 (33.33%)  2 2/6 (33.33%)  2 4/26 (15.38%)  4
Confusional state * 1  0/3 (0.00%)  0 2/3 (66.67%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0 1/26 (3.85%)  1
Depression * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/26 (3.85%)  1
Delusion * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Renal and urinary disorders           
Haematuria * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 1/26 (3.85%)  1
Urinary incontinence * 1  1/3 (33.33%)  1 2/3 (66.67%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Acute kidney injury * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Dysuria * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
Pollakiuria * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/26 (7.69%)  2
Renal haemorrhage * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Renal impairment * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  4 1/26 (3.85%)  4
Urinary retention * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Urinary tract pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders           
Dyspnoea * 1  0/3 (0.00%)  0 3/3 (100.00%)  5 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Oropharyngeal pain * 1  2/3 (66.67%)  2 1/3 (33.33%)  2 0/3 (0.00%)  0 1/6 (16.67%)  2 4/26 (15.38%)  5
Cough * 1  1/3 (33.33%)  1 2/3 (66.67%)  4 0/3 (0.00%)  0 0/6 (0.00%)  0 2/26 (7.69%)  4
Dysphonia * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 2/26 (7.69%)  2
Dyspnoea exertional * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/26 (3.85%)  1
Productive cough * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Hypoxia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 2/26 (7.69%)  2
Nasal congestion * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/26 (3.85%)  1
Pleural effusion * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Rhinorrhoea * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 2/26 (7.69%)  2
Tachypnoea * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Wheezing * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 2/26 (7.69%)  2
Skin and subcutaneous tissue disorders           
Ecchymosis * 1  1/3 (33.33%)  1 1/3 (33.33%)  2 1/3 (33.33%)  1 1/6 (16.67%)  1 1/26 (3.85%)  1
Rash erythematous * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Rash maculo-papular * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 5/26 (19.23%)  5
Dermatitis * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Dermatitis acneiform * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Dry skin * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Erythema * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Hyperhidrosis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/26 (7.69%)  2
Ingrowing nail * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Rash * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/26 (3.85%)  1
Skin ulcer * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/26 (3.85%)  1
Vascular disorders           
Hypotension * 1  0/3 (0.00%)  0 3/3 (100.00%)  3 1/3 (33.33%)  2 3/6 (50.00%)  4 6/26 (23.08%)  7
Hypertension * 1  1/3 (33.33%)  5 2/3 (66.67%)  12 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Deep vein thrombosis * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/26 (0.00%)  0
Jugular vein distension * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/26 (0.00%)  0
1
Term from vocabulary, MedDRA (19.1)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Operations
Organization: Pharmacyclics, LLC
Phone: 408-774-0330
EMail: Clinical_Directors@pcyc.com
Layout table for additonal information
Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02142049     History of Changes
Other Study ID Numbers: PCYC-1124-CA
First Submitted: May 12, 2014
First Posted: May 20, 2014
Results First Submitted: May 31, 2018
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019