A Pilot Study of Genetically Engineered NY-ESO-1 Specific... | NCT01343043

ID	Type	Description	Link
ADP 04511	Other Identifier	Adaptimmune Therapeutics
2015-005594-21	EudraCT Number

Label	Type	Description	Intervention Names
Cohort 1 treated with NY-ESO-1 T Cells	Experimental	High NY-ESO-1 expression and the use of cyclophosphamide plus fludarabine as the lymphodepleting chemotherapy.	Drug: NY-ESO-1(c259)T Cells Drug: Fludarabine Drug: Cyclophosphamide
Cohort 2 treated with NY-ESO-1 T Cells	Experimental	Low NY-ESO-1 expression and the use of cyclophosphamide plus fludarabine as the lymphodepleting chemotherapy.	Drug: NY-ESO-1(c259)T Cells Drug: Fludarabine Drug: Cyclophosphamide
Cohort 3 treated with NY-ESO-1 T Cells	Experimental	High NYESO-1 expression and the use of cyclophosphamide only for lymphodepletion rather than fludarabine as the lymphodepleting chemotherapy.	Drug: NY-ESO-1(c259)T Cells Drug: Cyclophosphamide
Cohort 4 treated with NY-ESO-1 T Cells	Experimental	High NY-ESO-1 expression and the use of reduced dose cyclophosphamide plus fludarabine regimen as the lymphodepleting chemotherapy.	Drug: NY-ESO-1(c259)T Cells Drug: Fludarabine Drug: Cyclophosphamide

Name	Type	Description	Arm Group Labels	Other Names
NY-ESO-1(c259)T Cells	Drug	Lymphodepleting chemotherapy followed by infusion with NY-ESO-1(c259) transduced autologous T cells. Subjects will receive one infusion of NY-ESO-1 genetically engineered T cells on Day 0.

Measure	Description	Time Frame
Objective Response Rate (ORR)	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.	Up to 4.5 years

Measure	Description	Time Frame
Duration of Overall Response	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.	Up to 4.5 years

Measure	Description	Time Frame
Number of Participants With Dose-limiting Toxicities (DLTs)	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. The results for this outcome measure will never be posted.	Up to Day 21 (from first dose)

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Duarte	California	91010	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
36075914	Derived	Gyurdieva A, Zajic S, Chang YF, Houseman EA, Zhong S, Kim J, Nathenson M, Faitg T, Woessner M, Turner DC, Hasan AN, Glod J, Kaplan RN, D'Angelo SP, Araujo DM, Chow WA, Druta M, Demetri GD, Van Tine BA, Grupp SA, Fine GD, Eleftheriadou I. Biomarker correlates with response to NY-ESO-1 TCR T cells in patients with synovial sarcoma. Nat Commun. 2022 Sep 8;13(1):5296. doi: 10.1038/s41467-022-32491-x.
31651363

ID	Title	Description
FG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 17, 2018	Apr 23, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Objective Response Rate (ORR)

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.

Modified intent-to-treat (mITT) Population comprised of all participants who received NY-ESO-1 genetically engineered T cell infusion

Posted

Number

Percentage of Participants

Up to 4.5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..
OG002	Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	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.
OG003	Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	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.

Units	Counts
Participants	OG00012 OG00113 OG0025 OG003

Title

Denominators

Categories

Title	Measurements
	OG00050 OG00130.8 OG00220 OG003

Secondary

Duration of Overall Response

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.

mITT Population. Only those participants with data available at the specified data points were analyzed.

Posted

Median

Full Range

Weeks

Up to 4.5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..

Secondary

Progression Free Survival

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.

mITT Population

Posted

Median

Inter-Quartile Range

Weeks

Up to 4.5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..

Secondary

Best Overall Response

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.

mITT Population

Posted

Count of Participants

Participants

Up to 4.5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..

Secondary

Overall Survival

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.

mITT Population

Posted

Median

Inter-Quartile Range

Weeks

Up to 4.5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..

Secondary

Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)

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.

Intent-to-treat (ITT) Population comprised of all participants who were enrolled in the study.

Posted

Count of Participants

Participants

Up to 5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A

Secondary

Number of Participants With Worst Post-Baseline Grade Results for Hematology Parameters

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.

mITT Population

Posted

Up to 4.5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..
OG002

Secondary

Number of Participants With Worst Post-Baseline Grade Results for Clinical Chemistry Parameters

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.

mITT Population

Posted

Up to 4.5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..
OG002

Secondary

Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-infused (NY-ESO-1 Genetically Engineered T) Cell Antibody Result

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.

mITT Population. Only those participants with data available at the specified data points were analyzed.

Posted

Count of Participants

Participants

Up to 4.5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A

Secondary

Concentration of Cytokines in Cytokine Release Syndrome (CRS) by CRS Status: Cohort 1: High NY-ESO-1 Expression Treated With Regimen A

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 correlation between cytokines and cytokine release syndrome was considered between participants who had serious CRS vs no CRS or Non-serious CRS. There were only 4 participants across the whole study that had serious CRS and cytokine data was available for 3 of these participants. Due to the limited number of participants that had serious CRS no statistical correlations in cytokine levels and CRS could be performed. A listing of the levels of cytokines for the 3 participants with serious CRS is available/provided.

mITT Population.

Posted

Up to Week 4

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.

Secondary

Concentration of Cytokines in CRS by CRS Status: Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A

mITT Population.

Posted

Up to Week 4

ID	Title	Description
OG000	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..

Units

Secondary

Concentration of Cytokines in CRS by CRS Status: Cohort 3: High NY-ESO-1 Expression Treated With Regimen B

mITT Population

Posted

Up to Week 4

ID	Title	Description
OG000	Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	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.

Units	Counts

Secondary

Concentration of Cytokines in CRS by CRS Status: Cohort 4: High NY-ESO-1 Expression Treated With Regimen C

mITT Population.

Posted

Up to Week 4

ID	Title	Description
OG000	Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	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.

Units	Counts

Secondary

Time to Maximum Persistence of NY-ESO-1 Genetically Engineered T Cells

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.

mITT Population. Only those participants with data available at the specified data points were analyzed.

Posted

Median

Full Range

Days

Up to 4.5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..

Other Pre-specified

Number of Participants With Dose-limiting Toxicities (DLTs)

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. The results for this outcome measure will never be posted.

mITT Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.

Posted

Up to Day 21 (from first dose)

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..

Other Pre-specified

Number of Participants With Clinically Significant Abnormal Electrocardiogram, Echocardiogram and Multigated Acquisition Scan Findings

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. The results for this outcome measure will never be posted.

mITT Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.

Posted

Up to 4.5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..

Other Pre-specified

Percentage of Participants With Confirmed CR

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. The results for this outcome measure will never be posted.

mITT Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.

Posted

Up to 4.5 years

ID	Title	Description
OG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
OG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected14 at risk EG0022 affected5 at risk EG0030 affected16 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Chills	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Embolism	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Hypotension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0013 affected14 at risk EG0020 affected5 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Anal ulcer	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0013 affected14 at risk EG0020 affected5 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Device related infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Lung infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Platelet count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
White blood cell count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG00012 affected15 at risk EG0018 affected14 at risk EG0023 affected5 at risk EG00314 affected16 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG00012 affected15 at risk EG00110 affected14 at risk EG0024 affected5 at risk EG003
Oedema peripheral	General disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0015 affected14 at risk EG0021 affected5 at risk EG003
Pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0012 affected14 at risk EG0022 affected5 at risk EG003
Chills	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0013 affected14 at risk EG0021 affected5 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0014 affected14 at risk EG0023 affected5 at risk EG003
Chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Asthenia	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Injection site reaction	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Chest discomfort	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Influenza like illness	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Malaise	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Mucosal inflammation	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Peripheral swelling	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Tenderness	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Catheter site bruise	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Catheter site irritation	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Catheter site pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Catheter site vesicles	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Face oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Facial pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Gait disturbance	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Generalised oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Infusion site extravasation	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Localised oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
White blood cell count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG00012 affected15 at risk EG00110 affected14 at risk EG0025 affected5 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG00013 affected15 at risk EG0018 affected14 at risk EG0023 affected5 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG00011 affected15 at risk EG0018 affected14 at risk EG0024 affected5 at risk EG003
Platelet count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG00012 affected15 at risk EG0017 affected14 at risk EG0024 affected5 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0006 affected15 at risk EG0014 affected14 at risk EG0023 affected5 at risk EG003
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0008 affected15 at risk EG0012 affected14 at risk EG0021 affected5 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA 22.0	Systematic Assessment	EG0009 affected15 at risk EG0013 affected14 at risk EG0022 affected5 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0007 affected15 at risk EG0014 affected14 at risk EG0022 affected5 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0007 affected15 at risk EG0011 affected14 at risk EG0022 affected5 at risk EG003
Weight decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0014 affected14 at risk EG0022 affected5 at risk EG003
Lipase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0006 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Amylase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0022 affected5 at risk EG003
Breath sounds abnormal	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected14 at risk EG0021 affected5 at risk EG003
C-reactive protein increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0022 affected5 at risk EG003
Ejection fraction decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0022 affected5 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
International normalised ratio increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Serum ferritin increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Urine output decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Blood pressure diastolic increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Cytomegalovirus test positive	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Electrocardiogram abnormal	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Epstein-Barr virus antibody positive	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Transaminases increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
White blood cells urine positive	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG00014 affected15 at risk EG00113 affected14 at risk EG0024 affected5 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0014 affected14 at risk EG0020 affected5 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0013 affected14 at risk EG0021 affected5 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0015 affected14 at risk EG0020 affected5 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0013 affected14 at risk EG0020 affected5 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00013 affected15 at risk EG00110 affected14 at risk EG0024 affected5 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0008 affected15 at risk EG0019 affected14 at risk EG0022 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0007 affected15 at risk EG0016 affected14 at risk EG0023 affected5 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0008 affected15 at risk EG0013 affected14 at risk EG0023 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0014 affected14 at risk EG0023 affected5 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected14 at risk EG0021 affected5 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Lip dry	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Oral dysaesthesia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Oral mucosal erythema	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Change of bowel habit	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Oral disorder	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Scalloped tongue	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0009 affected15 at risk EG0017 affected14 at risk EG0023 affected5 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00011 affected15 at risk EG0017 affected14 at risk EG0022 affected5 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0005 affected15 at risk EG0015 affected14 at risk EG0022 affected5 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00010 affected15 at risk EG0014 affected14 at risk EG0022 affected5 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0005 affected15 at risk EG0016 affected14 at risk EG0021 affected5 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0008 affected15 at risk EG0014 affected14 at risk EG0022 affected5 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0006 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0012 affected14 at risk EG0021 affected5 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected14 at risk EG0021 affected5 at risk EG003
Appetite disorder	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0008 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0007 affected15 at risk EG0012 affected14 at risk EG0022 affected5 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0014 affected14 at risk EG0022 affected5 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0005 affected15 at risk EG0012 affected14 at risk EG0021 affected5 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0012 affected14 at risk EG0021 affected5 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0012 affected14 at risk EG0021 affected5 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0013 affected14 at risk EG0020 affected5 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0008 affected15 at risk EG00110 affected14 at risk EG0023 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0009 affected15 at risk EG0016 affected14 at risk EG0023 affected5 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0013 affected14 at risk EG0023 affected5 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0006 affected15 at risk EG0010 affected14 at risk EG0022 affected5 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0014 affected14 at risk EG0022 affected5 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0014 affected14 at risk EG0023 affected5 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0011 affected14 at risk EG0022 affected5 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Hypopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Laryngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0007 affected15 at risk EG0017 affected14 at risk EG0022 affected5 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0014 affected14 at risk EG0022 affected5 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0022 affected5 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Palpitations	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Right ventricular dysfunction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0022 affected5 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Aortic valve disease	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Mitral valve disease	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Pulmonary valve disease	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Tricuspid valve disease	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0006 affected15 at risk EG0014 affected14 at risk EG0021 affected5 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0007 affected15 at risk EG0014 affected14 at risk EG0021 affected5 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0013 affected14 at risk EG0023 affected5 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0013 affected14 at risk EG0021 affected5 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Dermatitis exfoliative generalised	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0009 affected15 at risk EG0013 affected14 at risk EG0023 affected5 at risk EG003
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0008 affected15 at risk EG0011 affected14 at risk EG0023 affected5 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Lethargy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Migraine	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Presyncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0022 affected5 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Neurotoxicity	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Phantom limb syndrome	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Somnolence	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Tremor	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG00010 affected15 at risk EG0013 affected14 at risk EG0020 affected5 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0015 affected14 at risk EG0020 affected5 at risk EG003
Depression	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0013 affected14 at risk EG0020 affected5 at risk EG003
Agitation	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected14 at risk EG0021 affected5 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Paranoia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Social avoidant behaviour	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Hypotension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0018 affected14 at risk EG0022 affected5 at risk EG003
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0013 affected14 at risk EG0022 affected5 at risk EG003
Hot flush	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Embolism	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Flushing	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Pallor	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Vena cava thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0011 affected14 at risk EG0022 affected5 at risk EG003
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Device related infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Folliculitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Eye infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Groin infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Lung infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Paronychia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Pseudomonas infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Rhinitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Sinusitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Streptococcal bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Vaginal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Viral infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected15 at risk EG0015 affected14 at risk EG0023 affected5 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0013 affected14 at risk EG0020 affected5 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected14 at risk EG0022 affected5 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0013 affected14 at risk EG0020 affected5 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Urinary tract pain	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Haemoglobinuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Anuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Fanconi syndrome acquired	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Oliguria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Renal tubular acidosis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0021 affected5 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Incision site pain	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Vision blurred	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Dry eye	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Eye pruritus	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Photophobia	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0002 affected15 at risk EG0012 affected14 at risk EG0020 affected5 at risk EG003
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Premature menopause	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Genital rash	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Oedema genital	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Pruritus genital	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003
External ear inflammation	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0021 affected5 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected14 at risk EG0020 affected5 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected14 at risk EG0020 affected5 at risk EG003

ID	Term
D009369	Neoplasms
D012509	Sarcoma
D009362	Neoplasm Metastasis

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds

ID	Title	Description
BG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.
BG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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..
BG002	Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	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.
BG003	Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	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.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: High NY-ESO-1 Expression Treated With Regimen A	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.	12	15	9	15	15	15
EG001	Cohort 2: Low NY-ESO-1 Expression Treated With Regimen A	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.	13	14	7	14	13	14
EG002	Cohort 3: High NY-ESO-1 Expression Treated With Regimen B	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.	4	5	4	5	5	5
EG003	Cohort 4: High NY-ESO-1 Expression Treated With Regimen C	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.	8	16	6	16	15	16