Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma (NY-ESO-1)

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: NCT01343043
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : July 9, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition Neoplasms
Intervention Biological: NY-ESO-1(c259)T Cells
Enrollment 50
Recruitment Details This study was designed to determine whether New York esophageal squamous cell carcinoma 1 (NY-ESO-1) specific genetically engineered T cells recognized a human leukocyte antigens (HLA-A2) binding peptide from NY-ESO-1 induced antitumor responses in participants with synovial sarcoma.
Pre-assignment Details A total of 50 participants were enrolled in this study. Out of 50 participants, 45 participants received NY-ESO-1 genetically engineered T cell infusion.
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells. Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells.. Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells. Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Period Title: Overall Study
Started 15 14 5 16
Received T-cell Infusion 12 13 5 15
Completed 12 13 5 15
Not Completed 3 1 0 1
Reason Not Completed
Disease progression before treatment             1             0             0             0
Withdrawal by Subject             1             0             0             0
Death             1             1             0             1
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C Total
Hide Arm/Group Description Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells. Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells.. Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells. Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells. Total of all reporting groups
Overall Number of Baseline Participants 15 14 5 16 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 14 participants 5 participants 16 participants 50 participants
28.5  (10.00) 33.1  (16.18) 25.4  (8.73) 41.2  (13.80) 33.6  (14.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 5 participants 16 participants 50 participants
Female
8
  53.3%
7
  50.0%
2
  40.0%
8
  50.0%
25
  50.0%
Male
7
  46.7%
7
  50.0%
3
  60.0%
8
  50.0%
25
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 5 participants 16 participants 50 participants
Asian
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
1
   2.0%
Black or African American
1
   6.7%
0
   0.0%
1
  20.0%
1
   6.3%
3
   6.0%
White
13
  86.7%
11
  78.6%
4
  80.0%
15
  93.8%
43
  86.0%
Missing
1
   6.7%
2
  14.3%
0
   0.0%
0
   0.0%
3
   6.0%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR was calculated as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1 as determined by the local investigators.
Time Frame Up to 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) Population comprised of all participants who received NY-ESO-1 genetically engineered T cell infusion
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 12 13 5 15
Measure Type: Number
Unit of Measure: Percentage of Participants
50 30.8 20 26.7
2.Secondary Outcome
Title Duration of Overall Response
Hide Description Duration of overall response (DOR) is defined as the time from first documented evidence of confirmed CR or confirmed PR until first documented date of disease progression or death due to any cause or surgical resection or start of prohibited medications. Duration of overall response was evaluated per RECIST v1.1. Median and full range of DOR are presented.
Time Frame Up to 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 6 4 1 4
Median (Full Range)
Unit of Measure: Weeks
31.0
(13 to 72)
8.6
(8 to 13)
32.1 [1] 
(NA to NA)
16.4
(14 to 94)
[1]
Full range is not applicable due to single participant, and the median value presented here is the actual DOR for this single participant.
3.Secondary Outcome
Title Progression Free Survival
Hide Description Progression free survival is defined as the interval between the date of first T cell infusion and the earliest documented evidence of disease progression or death due to any cause or surgical resection or start of prohibited medications. Progression free survival was evaluated per RECIST v1.1. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.
Time Frame Up to 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 12 13 5 15
Median (Inter-Quartile Range)
Unit of Measure: Weeks
15.4
(8.6 to 37.1)
13.1
(8.3 to 13.9)
8.6
(8.3 to 12.1)
22.4
(11.6 to 38.3)
4.Secondary Outcome
Title Best Overall Response
Hide Description Best overall response is the best response recorded from the start of treatment (first T cell infusion) until disease progression/recurrence. Response categories from best to worst are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD). Best overall response is a stable disease, if CR or PR are unconfirmed. Data for number of participants with CR, PR, SD and PD are presented.
Time Frame Up to 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 12 13 5 15
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
Partial response
5
  41.7%
4
  30.8%
1
  20.0%
4
  26.7%
Stable disease
5
  41.7%
7
  53.8%
3
  60.0%
10
  66.7%
Progressive disease
1
   8.3%
1
   7.7%
0
   0.0%
1
   6.7%
Not evaluable
0
   0.0%
1
   7.7%
1
  20.0%
0
   0.0%
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the interval between the date of the first T-cell infusion and date of death from any cause. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented.
Time Frame Up to 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 12 13 5 15
Median (Inter-Quartile Range)
Unit of Measure: Weeks
80.7
(45.3 to 212.0)
43.1
(19.4 to 85.3)
86.4
(68.1 to 104.6)
105.3 [1] 
(50.3 to NA)
[1]
<75% of participants experienced the event within the treatment arm. Hence, third quartile could not be derived.
6.Secondary Outcome
Title Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Hide Description An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had non-SAEs and SAEs are presented.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population comprised of all participants who were enrolled in the study.
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 15 14 5 16
Measure Type: Count of Participants
Unit of Measure: Participants
Non-SAE
15
 100.0%
13
  92.9%
5
 100.0%
15
  93.8%
SAE
9
  60.0%
7
  50.0%
4
  80.0%
6
  37.5%
7.Secondary Outcome
Title Number of Participants With Worst Post-Baseline Grade Results for Hematology Parameters
Hide Description Blood samples were collected for the analysis of hematology parameters. No data collected separately for this outcome measure as any abnormal value would be recorded as an adverse event.
Time Frame Up to 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With Worst Post-Baseline Grade Results for Clinical Chemistry Parameters
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters. No data collected separately for this outcome measure as any abnormal value would be recorded as an adverse event.
Time Frame Up to 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-infused (NY-ESO-1 Genetically Engineered T) Cell Antibody Result
Hide Description Serum samples were collected for the determination of anti-infused (NY-ESO-1 genetically engineered T) cell antibodies (ATA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. A participant was considered to have a confirmed positive ATA result if they have a positive screening assay result and a positive confirmation assay result.
Time Frame Up to 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 10 8 3 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Concentration of Cytokines in Cytokine Release Syndrome (CRS) by CRS Status: Cohort 1: High NY-ESO-1 Expression Treated With Regimen A
Hide Description CRS is a potentially life-threatening toxicity that is observed following administration of antibodies and adoptive T-cell therapies for cancer. Serum samples were collected to analyze the concentration of cytokines using the electrochemiluminescent tagged detection antibodies. The concentration of cytokines was analyzed by participant's CRS status which was categorized by 'CRS none or none serious adverse events' and 'CRS serious adverse events'. Data for concentration of different cytokines like interferon (IFN) gamma, interleukin (IL)12, IL13, IL6, IL8, and tumor necrosis factor (TNF) is presented by 'CRS none or none serious adverse events' and 'CRS serious adverse events' for cohort 1 'High NY-ESO-1 expression treated with Regimen A'.
Time Frame Day 0 (pre-dose, 1, 2, 4, 8 and 12 hours post-dose), Day 1, Day 3, Day 4, Day 7, Week 2, Week 3 and Week 4
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Concentration of Cytokines in Cytokine Release Syndrome (CRS) by CRS Status: Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A
Hide Description CRS is a potentially life-threatening toxicity that is observed following administration of antibodies and adoptive T-cell therapies for cancer. Serum samples were collected to analyze the concentration of cytokines using the electrochemiluminescent tagged detection antibodies. The concentration of cytokines was analyzed by participant's CRS status which was categorized by 'CRS none or none serious adverse events' and 'CRS serious adverse events'. Data for concentration of different cytokines like IFN gamma, IL12, IL13, IL6, IL8, and TNF is presented by 'CRS none or none serious adverse events' and 'CRS serious adverse events' for cohort 2 'Low NY-ESO-1 expression treated with Regimen A'.
Time Frame Day 0 (pre-dose, 1, 2 and 4 hours post-dose), Day 1, Day 3, Day 4, Day 7, Week 2, Week 3 and Week 4
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Concentration of Cytokines in Cytokine Release Syndrome (CRS) by CRS Status: Cohort 3: High NY-ESO-1 Expression Treated With Regimen B
Hide Description CRS is a potentially life-threatening toxicity that is observed following administration of antibodies and adoptive T-cell therapies for cancer. Serum samples were collected to analyze the concentration of cytokines using the electrochemiluminescent tagged detection antibodies. The concentration of cytokines was analyzed by participant's CRS status which was categorized by 'CRS none or none serious adverse events'. Data for concentration of different cytokines like IFN gamma, IL12, IL13, IL6, IL8, and TNF is presented by 'CRS none or none serious adverse events' for Cohort 3 'High NY-ESO-1 expression treated with Regimen B'.
Time Frame Day 0 (pre-dose and post-dose), Day 1, Day 3, Day 4, Day 7, Week 2, Week 3 and Week 4
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Concentration of Cytokines in Cytokine Release Syndrome (CRS) by CRS Status: Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Description CRS is a potentially life-threatening toxicity that is observed following administration of antibodies and adoptive T-cell therapies for cancer. Serum samples were collected to analyze the concentration of cytokines using the electrochemiluminescent tagged detection antibodies. The concentration of cytokines was analyzed by participant's CRS status which was categorized by 'CRS none or none serious adverse events'. Data for concentration of different cytokines like IFN gamma, IL12, IL13, IL6, IL8, and TNF is presented by 'CRS none or none serious adverse events' for Cohort 4 'High NY-ESO-1 expression treated with Regimen C'.
Time Frame Day 0 (pre-dose, 1 and 2 hours post-dose), Day 1, Day 4, Day 7, Week 2, Week 3 and Week 4
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Time to Maximum Persistence of NY-ESO-1 Genetically Engineered T Cells
Hide Description Time to maximum persistence is defined as date of maximum persistence for infusion visit minus date of first T cell infusion visit plus 1. Median and full range of time to maximum persistence are presented.
Time Frame Up to 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 6 4 1 4
Median (Full Range)
Unit of Measure: Days
8.0
(4 to 29)
8.0
(5 to 18)
8.0
(8 to 8)
9
(6 to 13)
15.Other Pre-specified Outcome
Title Number of Participants With Dose-limiting Toxicities (DLTs)
Hide Description DLT was planned to be evaluated. An event was to be considered a DLT if it occurred within the first 21 days of treatment, and met one of the protocol defined DLT criteria.
Time Frame Up to Day 21 (from first dose)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Abnormal Electrocardiogram, Echocardiogram and Multigated Acquisition Scan Findings
Hide Description Abnormal electrocardiogram, echocardiogram and multigated acquisition scan findings were planned to be evaluated. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.
Time Frame Up to 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Other Pre-specified Outcome
Title Percentage of Participants With Confirmed CR
Hide Description Participants were planned to be evaluated for confirmed CR according to RECIST v1.1, after receiving a second dose of NY-ESO-1 genetically engineered T cell infusion
Time Frame Up to 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description:
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells..
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment (Day 1) until maximum of 4.5 years
Adverse Event Reporting Description SAEs and non-serious AEs were reported for the ITT Population which comprised of all participants who were enrolled in the study.
 
Arm/Group Title Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Hide Arm/Group Description Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, intravenously [IV] and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells. Participants with low tumor expression of NY-ESO-1 underwent lymphodepletion with regimen A (lymphodepleting chemotherapeutic agents; cyclophosphamide plus fludarabine on Days -3 and -2, IV and only fludarabine on Days -5 and -4, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. Low tumor NY-ESO-1 expression was defined as >=1+ by IHC in >=1% cells but not to exceed 2+ or 3+ in >=50% cells. Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen B (lymphodepleting chemotherapeutic agent; cyclophosphamide only on Days -3 and -2, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells. Participants with high tumor expression of NY-ESO-1 underwent lymphodepletion with regimen C (lymphodepleting chemotherapeutic agents; reduced dose of cyclophosphamide plus fludarabine on Days -7 to -5, IV). Participants received one infusion of NY-ESO-1 genetically engineered T cells on Day 0. High tumor NY-ESO-1 expression was defined as 2+ or 3+ by immunohistochemistry (IHC) in >=50% cells.
All-Cause Mortality
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/15 (80.00%)   13/14 (92.86%)   4/5 (80.00%)   8/16 (50.00%) 
Hide Serious Adverse Events
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/15 (60.00%)   7/14 (50.00%)   4/5 (80.00%)   6/16 (37.50%) 
Blood and lymphatic system disorders         
Febrile neutropenia  1  2/15 (13.33%)  1/14 (7.14%)  0/5 (0.00%)  2/16 (12.50%) 
Bone marrow failure  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Anaemia  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Neutropenia  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Cardiac disorders         
Myocardial infarction  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Pericardial effusion  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Supraventricular tachycardia  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Gastrointestinal disorders         
Diarrhoea  1  0/15 (0.00%)  2/14 (14.29%)  0/5 (0.00%)  0/16 (0.00%) 
Abdominal pain  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Anal ulcer  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Enterocolitis  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Nausea  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Proctalgia  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Vomiting  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
General disorders         
Pyrexia  1  4/15 (26.67%)  1/14 (7.14%)  0/5 (0.00%)  3/16 (18.75%) 
Chills  1  2/15 (13.33%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Chest pain  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Non-cardiac chest pain  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Hepatobiliary disorders         
Cholecystitis acute  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Immune system disorders         
Cytokine release syndrome  1  1/15 (6.67%)  3/14 (21.43%)  0/5 (0.00%)  1/16 (6.25%) 
Infections and infestations         
Bacteraemia  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Cytomegalovirus infection  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Device related infection  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Lung infection  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Injury, poisoning and procedural complications         
Vascular access complication  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Investigations         
Neutrophil count decreased  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Platelet count decreased  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
White blood cell count decreased  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Hypokalaemia  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Leukaemia  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Tumour haemorrhage  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Tumour pain  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Nervous system disorders         
Guillain-Barre syndrome  1  0/15 (0.00%)  2/14 (14.29%)  0/5 (0.00%)  0/16 (0.00%) 
Spinal cord compression  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Renal and urinary disorders         
Acute kidney injury  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  2/15 (13.33%)  1/14 (7.14%)  2/5 (40.00%)  0/16 (0.00%) 
Pneumothorax  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  2/16 (12.50%) 
Hypoxia  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Pleural effusion  1  0/15 (0.00%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Respiratory failure  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Cough  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Haemoptysis  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Pleuritic pain  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Pneumonitis  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Pulmonary haemorrhage  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash maculo-papular  1  2/15 (13.33%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Vascular disorders         
Embolism  1  2/15 (13.33%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Hypotension  1  0/15 (0.00%)  3/14 (21.43%)  0/5 (0.00%)  0/16 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: High NY-ESO-1 Expression Treated With Regimen A Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A Cohort 3: High NY-ESO-1 Expression Treated With Regimen B Cohort 4: High NY-ESO-1 Expression Treated With Regimen C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/15 (100.00%)   13/14 (92.86%)   5/5 (100.00%)   15/16 (93.75%) 
Blood and lymphatic system disorders         
Anaemia  1  14/15 (93.33%)  13/14 (92.86%)  4/5 (80.00%)  9/16 (56.25%) 
Febrile neutropenia  1  3/15 (20.00%)  4/14 (28.57%)  0/5 (0.00%)  6/16 (37.50%) 
Neutropenia  1  0/15 (0.00%)  3/14 (21.43%)  1/5 (20.00%)  7/16 (43.75%) 
Thrombocytopenia  1  1/15 (6.67%)  5/14 (35.71%)  0/5 (0.00%)  4/16 (25.00%) 
Leukopenia  1  0/15 (0.00%)  3/14 (21.43%)  0/5 (0.00%)  0/16 (0.00%) 
Leukocytosis  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  2/16 (12.50%) 
Cardiac disorders         
Sinus tachycardia  1  7/15 (46.67%)  7/14 (50.00%)  2/5 (40.00%)  4/16 (25.00%) 
Tachycardia  1  4/15 (26.67%)  4/14 (28.57%)  2/5 (40.00%)  6/16 (37.50%) 
Pericardial effusion  1  1/15 (6.67%)  0/14 (0.00%)  2/5 (40.00%)  1/16 (6.25%) 
Sinus bradycardia  1  2/15 (13.33%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Atrial fibrillation  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  1/16 (6.25%) 
Palpitations  1  2/15 (13.33%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Right ventricular dysfunction  1  0/15 (0.00%)  0/14 (0.00%)  2/5 (40.00%)  0/16 (0.00%) 
Angina pectoris  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Aortic valve disease  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Arrhythmia  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Atrial flutter  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Bradycardia  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Cardiac tamponade  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Cardiomyopathy  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Mitral valve disease  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Pulmonary valve disease  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Tricuspid valve disease  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Ear and labyrinth disorders         
Ear pain  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Eustachian tube dysfunction  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
External ear inflammation  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Endocrine disorders         
Hyperthyroidism  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Hypothyroidism  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Eye disorders         
Vision blurred  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  2/16 (12.50%) 
Dry eye  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Eye pruritus  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Eyelid ptosis  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Periorbital oedema  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Photophobia  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Gastrointestinal disorders         
Nausea  1  13/15 (86.67%)  10/14 (71.43%)  4/5 (80.00%)  13/16 (81.25%) 
Diarrhoea  1  8/15 (53.33%)  9/14 (64.29%)  2/5 (40.00%)  5/16 (31.25%) 
Vomiting  1  7/15 (46.67%)  6/14 (42.86%)  3/5 (60.00%)  6/16 (37.50%) 
Constipation  1  8/15 (53.33%)  3/14 (21.43%)  3/5 (60.00%)  7/16 (43.75%) 
Abdominal pain  1  4/15 (26.67%)  4/14 (28.57%)  3/5 (60.00%)  3/16 (18.75%) 
Dyspepsia  1  1/15 (6.67%)  2/14 (14.29%)  1/5 (20.00%)  3/16 (18.75%) 
Abdominal distension  1  1/15 (6.67%)  1/14 (7.14%)  1/5 (20.00%)  2/16 (12.50%) 
Dysphagia  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  3/16 (18.75%) 
Proctalgia  1  3/15 (20.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Abdominal pain upper  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  1/16 (6.25%) 
Dry mouth  1  0/15 (0.00%)  1/14 (7.14%)  1/5 (20.00%)  1/16 (6.25%) 
Gastritis  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  1/16 (6.25%) 
Gastrooesophageal reflux disease  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  2/16 (12.50%) 
Stomatitis  1  2/15 (13.33%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Lip dry  1  0/15 (0.00%)  2/14 (14.29%)  0/5 (0.00%)  0/16 (0.00%) 
Oral dysaesthesia  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Oral mucosal erythema  1  0/15 (0.00%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Ascites  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Change of bowel habit  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Gastrointestinal pain  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Haemorrhoidal haemorrhage  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Ileus  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Mouth ulceration  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Oral disorder  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Oral pain  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Scalloped tongue  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Small intestinal obstruction  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
General disorders         
Fatigue  1  12/15 (80.00%)  8/14 (57.14%)  3/5 (60.00%)  14/16 (87.50%) 
Pyrexia  1  12/15 (80.00%)  10/14 (71.43%)  4/5 (80.00%)  9/16 (56.25%) 
Oedema peripheral  1  4/15 (26.67%)  5/14 (35.71%)  1/5 (20.00%)  3/16 (18.75%) 
Pain  1  3/15 (20.00%)  2/14 (14.29%)  2/5 (40.00%)  6/16 (37.50%) 
Chills  1  2/15 (13.33%)  3/14 (21.43%)  1/5 (20.00%)  3/16 (18.75%) 
Non-cardiac chest pain  1  1/15 (6.67%)  4/14 (28.57%)  3/5 (60.00%)  0/16 (0.00%) 
Chest pain  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  4/16 (25.00%) 
Asthenia  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  3/16 (18.75%) 
Injection site reaction  1  2/15 (13.33%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Chest discomfort  1  0/15 (0.00%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Influenza like illness  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  2/16 (12.50%) 
Malaise  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Mucosal inflammation  1  0/15 (0.00%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Multiple organ dysfunction syndrome  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Peripheral swelling  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  1/16 (6.25%) 
Tenderness  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Catheter site bruise  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Catheter site irritation  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Catheter site pain  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Catheter site vesicles  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Face oedema  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Facial pain  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Gait disturbance  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Generalised oedema  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Infusion site extravasation  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Localised oedema  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Oedema  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  2/16 (12.50%) 
Immune system disorders         
Cytokine release syndrome  1  4/15 (26.67%)  5/14 (35.71%)  3/5 (60.00%)  4/16 (25.00%) 
Hypersensitivity  1  0/15 (0.00%)  3/14 (21.43%)  0/5 (0.00%)  0/16 (0.00%) 
Drug hypersensitivity  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Seasonal allergy  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Infections and infestations         
Upper respiratory tract infection  1  4/15 (26.67%)  1/14 (7.14%)  2/5 (40.00%)  1/16 (6.25%) 
Pneumonia  1  2/15 (13.33%)  1/14 (7.14%)  0/5 (0.00%)  1/16 (6.25%) 
Urinary tract infection  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  2/16 (12.50%) 
Device related infection  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  1/16 (6.25%) 
Folliculitis  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Abscess  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Acute sinusitis  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Beta haemolytic streptococcal infection  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Bronchitis  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Clostridium difficile colitis  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Cytomegalovirus infection  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Diverticulitis  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Eye infection  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Groin infection  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Herpes zoster  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Lung infection  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Nasopharyngitis  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Oral candidiasis  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Paronychia  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Pseudomonas infection  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Rhinitis  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Rhinovirus infection  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Sinusitis  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Staphylococcal infection  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Streptococcal bacteraemia  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Vaginal infection  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Viral infection  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Injury, poisoning and procedural complications         
Contusion  1  1/15 (6.67%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Fall  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Incision site pain  1  1/15 (6.67%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Transfusion reaction  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  1/16 (6.25%) 
Infusion related reaction  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Limb injury  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Procedural pain  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Skin abrasion  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Investigations         
White blood cell count decreased  1  12/15 (80.00%)  10/14 (71.43%)  5/5 (100.00%)  12/16 (75.00%) 
Lymphocyte count decreased  1  13/15 (86.67%)  8/14 (57.14%)  3/5 (60.00%)  7/16 (43.75%) 
Neutrophil count decreased  1  11/15 (73.33%)  8/14 (57.14%)  4/5 (80.00%)  7/16 (43.75%) 
Platelet count decreased  1  12/15 (80.00%)  7/14 (50.00%)  4/5 (80.00%)  7/16 (43.75%) 
Alanine aminotransferase increased  1  6/15 (40.00%)  4/14 (28.57%)  3/5 (60.00%)  4/16 (25.00%) 
Blood creatinine increased  1  8/15 (53.33%)  2/14 (14.29%)  1/5 (20.00%)  4/16 (25.00%) 
Activated partial thromboplastin time prolonged  1  9/15 (60.00%)  3/14 (21.43%)  2/5 (40.00%)  0/16 (0.00%) 
Aspartate aminotransferase increased  1  7/15 (46.67%)  4/14 (28.57%)  2/5 (40.00%)  1/16 (6.25%) 
Blood alkaline phosphatase increased  1  7/15 (46.67%)  1/14 (7.14%)  2/5 (40.00%)  2/16 (12.50%) 
Weight decreased  1  2/15 (13.33%)  4/14 (28.57%)  2/5 (40.00%)  2/16 (12.50%) 
Lipase increased  1  6/15 (40.00%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Amylase increased  1  2/15 (13.33%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Blood bilirubin increased  1  2/15 (13.33%)  1/14 (7.14%)  0/5 (0.00%)  1/16 (6.25%) 
Blood creatine phosphokinase increased  1  1/15 (6.67%)  0/14 (0.00%)  2/5 (40.00%)  1/16 (6.25%) 
Breath sounds abnormal  1  0/15 (0.00%)  2/14 (14.29%)  1/5 (20.00%)  1/16 (6.25%) 
C-reactive protein increased  1  0/15 (0.00%)  1/14 (7.14%)  2/5 (40.00%)  0/16 (0.00%) 
Ejection fraction decreased  1  0/15 (0.00%)  0/14 (0.00%)  2/5 (40.00%)  0/16 (0.00%) 
Haemoglobin decreased  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  2/16 (12.50%) 
International normalised ratio increased  1  2/15 (13.33%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Serum ferritin increased  1  0/15 (0.00%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Urine output decreased  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Blood pressure diastolic increased  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Cytomegalovirus test positive  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Electrocardiogram QT prolonged  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Electrocardiogram abnormal  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Epstein-Barr virus antibody positive  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Transaminases increased  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
White blood cells urine positive  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Metabolism and nutrition disorders         
Hypophosphataemia  1  9/15 (60.00%)  7/14 (50.00%)  3/5 (60.00%)  6/16 (37.50%) 
Hyponatraemia  1  11/15 (73.33%)  7/14 (50.00%)  2/5 (40.00%)  2/16 (12.50%) 
Decreased appetite  1  5/15 (33.33%)  5/14 (35.71%)  2/5 (40.00%)  7/16 (43.75%) 
Hypoalbuminaemia  1  10/15 (66.67%)  4/14 (28.57%)  2/5 (40.00%)  2/16 (12.50%) 
Hypokalaemia  1  5/15 (33.33%)  6/14 (42.86%)  1/5 (20.00%)  6/16 (37.50%) 
Hypocalcaemia  1  8/15 (53.33%)  4/14 (28.57%)  2/5 (40.00%)  2/16 (12.50%) 
Hypomagnesaemia  1  6/15 (40.00%)  1/14 (7.14%)  0/5 (0.00%)  5/16 (31.25%) 
Dehydration  1  3/15 (20.00%)  2/14 (14.29%)  1/5 (20.00%)  1/16 (6.25%) 
Hyperglycaemia  1  3/15 (20.00%)  2/14 (14.29%)  0/5 (0.00%)  2/16 (12.50%) 
Hyperkalaemia  1  4/15 (26.67%)  0/14 (0.00%)  1/5 (20.00%)  1/16 (6.25%) 
Hypermagnesaemia  1  1/15 (6.67%)  2/14 (14.29%)  1/5 (20.00%)  1/16 (6.25%) 
Appetite disorder  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Hyperchloraemia  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Hyperphosphataemia  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Hyperuricaemia  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Hypoglycaemia  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Lactic acidosis  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Metabolic acidosis  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Vitamin D deficiency  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal chest pain  1  8/15 (53.33%)  2/14 (14.29%)  0/5 (0.00%)  5/16 (31.25%) 
Pain in extremity  1  7/15 (46.67%)  2/14 (14.29%)  2/5 (40.00%)  4/16 (25.00%) 
Back pain  1  3/15 (20.00%)  4/14 (28.57%)  2/5 (40.00%)  5/16 (31.25%) 
Myalgia  1  5/15 (33.33%)  2/14 (14.29%)  1/5 (20.00%)  5/16 (31.25%) 
Arthralgia  1  4/15 (26.67%)  2/14 (14.29%)  1/5 (20.00%)  4/16 (25.00%) 
Musculoskeletal pain  1  4/15 (26.67%)  2/14 (14.29%)  1/5 (20.00%)  2/16 (12.50%) 
Neck pain  1  2/15 (13.33%)  1/14 (7.14%)  1/5 (20.00%)  3/16 (18.75%) 
Bone pain  1  1/15 (6.67%)  2/14 (14.29%)  0/5 (0.00%)  1/16 (6.25%) 
Flank pain  1  0/15 (0.00%)  3/14 (21.43%)  0/5 (0.00%)  1/16 (6.25%) 
Muscular weakness  1  2/15 (13.33%)  0/14 (0.00%)  0/5 (0.00%)  2/16 (12.50%) 
Muscle spasms  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  2/16 (12.50%) 
Pain in jaw  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  2/16 (12.50%) 
Joint range of motion decreased  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Limb discomfort  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Mobility decreased  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Musculoskeletal discomfort  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Trismus  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tumour pain  1  2/15 (13.33%)  2/14 (14.29%)  0/5 (0.00%)  2/16 (12.50%) 
Infected neoplasm  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Neoplasm skin  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Nervous system disorders         
Dizziness  1  9/15 (60.00%)  3/14 (21.43%)  3/5 (60.00%)  4/16 (25.00%) 
Headache  1  8/15 (53.33%)  1/14 (7.14%)  3/5 (60.00%)  7/16 (43.75%) 
Paraesthesia  1  4/15 (26.67%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Peripheral sensory neuropathy  1  2/15 (13.33%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Dysgeusia  1  2/15 (13.33%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Neuralgia  1  2/15 (13.33%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Disturbance in attention  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  1/16 (6.25%) 
Lethargy  1  0/15 (0.00%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Migraine  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Peripheral motor neuropathy  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Presyncope  1  0/15 (0.00%)  0/14 (0.00%)  2/5 (40.00%)  0/16 (0.00%) 
Dysarthria  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Memory impairment  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Neuropathy peripheral  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Neurotoxicity  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Peripheral sensorimotor neuropathy  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Phantom limb syndrome  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Somnolence  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Tremor  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Psychiatric disorders         
Anxiety  1  10/15 (66.67%)  3/14 (21.43%)  0/5 (0.00%)  6/16 (37.50%) 
Insomnia  1  4/15 (26.67%)  5/14 (35.71%)  0/5 (0.00%)  3/16 (18.75%) 
Depression  1  3/15 (20.00%)  1/14 (7.14%)  1/5 (20.00%)  1/16 (6.25%) 
Confusional state  1  1/15 (6.67%)  3/14 (21.43%)  0/5 (0.00%)  1/16 (6.25%) 
Agitation  1  1/15 (6.67%)  2/14 (14.29%)  1/5 (20.00%)  0/16 (0.00%) 
Mental status changes  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Paranoia  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Restlessness  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Sleep disorder  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Social avoidant behaviour  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Suicidal ideation  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Renal and urinary disorders         
Proteinuria  1  1/15 (6.67%)  2/14 (14.29%)  2/5 (40.00%)  1/16 (6.25%) 
Haematuria  1  1/15 (6.67%)  3/14 (21.43%)  0/5 (0.00%)  0/16 (0.00%) 
Acute kidney injury  1  0/15 (0.00%)  2/14 (14.29%)  0/5 (0.00%)  1/16 (6.25%) 
Urinary tract pain  1  1/15 (6.67%)  2/14 (14.29%)  0/5 (0.00%)  0/16 (0.00%) 
Dysuria  1  0/15 (0.00%)  2/14 (14.29%)  0/5 (0.00%)  0/16 (0.00%) 
Haemoglobinuria  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  1/16 (6.25%) 
Pollakiuria  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Anuria  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Chromaturia  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Chronic kidney disease  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Fanconi syndrome acquired  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Glycosuria  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Micturition urgency  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Oliguria  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Renal tubular acidosis  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Urinary retention  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Reproductive system and breast disorders         
Premature menopause  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Genital rash  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Menorrhagia  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Menstruation irregular  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Oedema genital  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Pelvic pain  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Pruritus genital  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Vaginal discharge  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Vaginal haemorrhage  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Vulvovaginal dryness  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  8/15 (53.33%)  10/14 (71.43%)  3/5 (60.00%)  7/16 (43.75%) 
Cough  1  9/15 (60.00%)  6/14 (42.86%)  3/5 (60.00%)  3/16 (18.75%) 
Hypoxia  1  2/15 (13.33%)  3/14 (21.43%)  3/5 (60.00%)  2/16 (12.50%) 
Nasal congestion  1  6/15 (40.00%)  0/14 (0.00%)  2/5 (40.00%)  2/16 (12.50%) 
Pleural effusion  1  3/15 (20.00%)  4/14 (28.57%)  2/5 (40.00%)  1/16 (6.25%) 
Tachypnoea  1  1/15 (6.67%)  4/14 (28.57%)  3/5 (60.00%)  0/16 (0.00%) 
Oropharyngeal pain  1  3/15 (20.00%)  1/14 (7.14%)  2/5 (40.00%)  1/16 (6.25%) 
Pleuritic pain  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  2/16 (12.50%) 
Dysphonia  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  1/16 (6.25%) 
Productive cough  1  3/15 (20.00%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Rhinitis allergic  1  3/15 (20.00%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Rhinorrhoea  1  1/15 (6.67%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Throat irritation  1  0/15 (0.00%)  2/14 (14.29%)  0/5 (0.00%)  1/16 (6.25%) 
Atelectasis  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Dyspnoea exertional  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Epistaxis  1  2/15 (13.33%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Haemoptysis  1  1/15 (6.67%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Pulmonary embolism  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  2/16 (12.50%) 
Wheezing  1  0/15 (0.00%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Aspiration  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Hiccups  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Hypopnoea  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Laryngeal haemorrhage  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Nasal dryness  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Pneumonitis  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Pneumothorax  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Pulmonary haemorrhage  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Pulmonary oedema  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  6/15 (40.00%)  4/14 (28.57%)  1/5 (20.00%)  2/16 (12.50%) 
Rash maculo-papular  1  7/15 (46.67%)  4/14 (28.57%)  1/5 (20.00%)  1/16 (6.25%) 
Alopecia  1  1/15 (6.67%)  3/14 (21.43%)  3/5 (60.00%)  3/16 (18.75%) 
Rash  1  2/15 (13.33%)  3/14 (21.43%)  1/5 (20.00%)  1/16 (6.25%) 
Dry skin  1  2/15 (13.33%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Erythema  1  0/15 (0.00%)  2/14 (14.29%)  0/5 (0.00%)  1/16 (6.25%) 
Skin hyperpigmentation  1  1/15 (6.67%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Acne  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  1/16 (6.25%) 
Dermatitis acneiform  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  1/16 (6.25%) 
Dermatitis exfoliative generalised  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Hyperhidrosis  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  1/16 (6.25%) 
Night sweats  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  2/16 (12.50%) 
Pain of skin  1  2/15 (13.33%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Skin exfoliation  1  0/15 (0.00%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Angioedema  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Cold sweat  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Dermatitis  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Ecchymosis  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Nail disorder  1  0/15 (0.00%)  0/14 (0.00%)  0/5 (0.00%)  1/16 (6.25%) 
Onychomadesis  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  0/16 (0.00%) 
Petechiae  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Purpura  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Rash erythematous  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Rash macular  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Rash papular  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Skin discolouration  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Skin ulcer  1  1/15 (6.67%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Subcutaneous emphysema  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Vascular disorders         
Hypotension  1  4/15 (26.67%)  8/14 (57.14%)  2/5 (40.00%)  7/16 (43.75%) 
Hypertension  1  2/15 (13.33%)  3/14 (21.43%)  2/5 (40.00%)  5/16 (31.25%) 
Hot flush  1  3/15 (20.00%)  0/14 (0.00%)  0/5 (0.00%)  0/16 (0.00%) 
Embolism  1  0/15 (0.00%)  1/14 (7.14%)  1/5 (20.00%)  0/16 (0.00%) 
Flushing  1  1/15 (6.67%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Pallor  1  0/15 (0.00%)  0/14 (0.00%)  1/5 (20.00%)  1/16 (6.25%) 
Deep vein thrombosis  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
Vena cava thrombosis  1  0/15 (0.00%)  1/14 (7.14%)  0/5 (0.00%)  0/16 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01343043    
Other Study ID Numbers: 208466
ADP 04511 ( Other Identifier: Adaptimmune Therapeutics )
2015-005594-21 ( EudraCT Number )
First Submitted: April 26, 2011
First Posted: April 27, 2011
Results First Submitted: June 18, 2020
Results First Posted: July 9, 2020
Last Update Posted: July 9, 2020