MAGE-A4ᶜ¹º³²T for Multi-Tumor | NCT03132922

Label	Type	Description	Intervention Names
Autologous genetically modified MAGE-A4ᶜ¹º³²T cells	Experimental		Genetic: Autologous genetically modified MAGE-A4ᶜ¹º³²T cells
Radiation Sub-Study: Autologous genetically modified MAGE-A4c1	Experimental		Radiation: Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation

Name	Type	Description	Arm Group Labels	Other Names
Autologous genetically modified MAGE-A4ᶜ¹º³²T cells	Genetic	Infusion of autologous genetically modified MAGE-A4ᶜ¹º³²T on Day 1	Autologous genetically modified MAGE-A4ᶜ¹º³²T cells

Measure	Description	Time Frame
Adverse Events (AE) Including Serious Adverse Events (SAE)	An AE was defined as any untoward medical occurrence in a clinical study participant who received a pharmaceutical product, regardless of causality. An AE was , therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AEs (including SAEs) are presented.	From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years).
Peak Persistence	Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).	From afamitresgene autoleucel infusion up to 18 months post-infusion
Replication Competent Lentivirus (RCL)	The presence of RCL was assessed by quantitative polymerase chain reaction (qPCR) targeting a segment of the vesicular stomatitis virus glycoprotein (VSV-G) coding sequence.	From afamitresgene autoleucel infusion to 3 months post-infusion

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR, defined as the proportion of participants with Best Overall Response (BOR) of confirmed completed response (CR) or partial response (PR) among participants with measurable disease at Baseline. The ORR was based on the assessment of response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by local radiologist. Participants with unknown or missing response were treated as non-responders.

Name	Affiliation	Role
David Hong, MD	M.D. Anderson Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami		Miami	Florida	33136	United States
Moffitt Cancer Center

PubMed Identifier	Type	Citation	Retractions
36624315	Derived	Hong DS, Van Tine BA, Biswas S, McAlpine C, Johnson ML, Olszanski AJ, Clarke JM, Araujo D, Blumenschein GR Jr, Kebriaei P, Lin Q, Tipping AJ, Sanderson JP, Wang R, Trivedi T, Annareddy T, Bai J, Rafail S, Sun A, Fernandes L, Navenot JM, Bushman FD, Everett JK, Karadeniz D, Broad R, Isabelle M, Naidoo R, Bath N, Betts G, Wolchinsky Z, Batrakou DG, Van Winkle E, Elefant E, Ghobadi A, Cashen A, Grand'Maison A, McCarthy P, Fracasso PM, Norry E, Williams D, Druta M, Liebner DA, Odunsi K, Butler MO. Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial. Nat Med. 2023 Jan;29(1):104-114. doi: 10.1038/s41591-022-02128-z. Epub 2023 Jan 9.
32002290

ID	Title	Description
FG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 (±20%) transduced cells
FG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 4, 2019	May 22, 2024

ID	Title	Description
BG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 (±20%) transduced cells
BG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells
BG002	Afamitresgene Autoleucel, Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells
BG003	Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel	Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10^9 transduced cells).
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG0013 BG00232 BG0034 BG00442

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

Adverse Events (AE) Including Serious Adverse Events (SAE)

An AE was defined as any untoward medical occurrence in a clinical study participant who received a pharmaceutical product, regardless of causality. An AE was , therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AEs (including SAEs) are presented.

Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel

Posted

Count of Participants

Participants

From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years).

ID	Title	Description
OG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 transduced cells
OG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells
OG002	Afamitresgene Autoleucel, Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells
OG003	Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel	Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.

Units	Counts
Participants	OG0003 OG0013 OG00232 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0013 OG00232 OG003

Primary

Peak Persistence

Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).

Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel and had a post-infusion sample tested for persistence

Posted

Mean

Standard Deviation

DNA copies/microgram

From afamitresgene autoleucel infusion up to 18 months post-infusion

ID	Title	Description
OG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 transduced cells
OG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells
OG002	Afamitresgene Autoleucel Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells
OG003	Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel	Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10^9 transduced cells).

Primary

Replication Competent Lentivirus (RCL)

The presence of RCL was assessed by quantitative polymerase chain reaction (qPCR) targeting a segment of the vesicular stomatitis virus glycoprotein (VSV-G) coding sequence.

Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel and had a post-infusion sample tested for VSV-G by qPCR (RCL)

Posted

Count of Participants

Participants

From afamitresgene autoleucel infusion to 3 months post-infusion

ID	Title	Description
OG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 transduced cells
OG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells
OG002	Afamitresgene Autoleucel, Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells
OG003	Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel

Secondary

Overall Response Rate (ORR)

ORR, defined as the proportion of participants with Best Overall Response (BOR) of confirmed completed response (CR) or partial response (PR) among participants with measurable disease at Baseline. The ORR was based on the assessment of response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by local radiologist. Participants with unknown or missing response were treated as non-responders.

mITT Population: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel

Posted

Count of Participants

Participants

From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)

ID	Title	Description
OG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 transduced cells
OG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells
OG002	Afamitresgene Autoleucel, Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells
OG003

Secondary

Best Overall Response (BOR)

BOR was defined as the best response recorded from the date of T-cell infusion until disease progression. Response categories from best to worst were, confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) (per RECIST v1.1)

Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel

Posted

Count of Participants

Participants

From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)

ID	Title	Description
OG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 transduced cells
OG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells
OG002	Afamitresgene Autoleucel, Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells
OG003	Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel

Secondary

Time to Response (TTR)

TTR was defined as the interval between the date of the first T-cell infusion and the earliest date of the first documented confirmed CR or confirmed PR.

Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel achieving CR or PR.

Posted

Median

95% Confidence Interval

Weeks

From afamitresgene autoleucel infusion until first documented confirmed CR or PR

ID	Title	Description
OG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 transduced cells
OG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells
OG002	Afamitresgene Autoleucel, Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells
OG003	Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel	Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.

Secondary

Duration of Response (DoR)

DoR was measured from the first CR/PR (whichever was first recorded) until the first date of progressive disease.

No patients in Groups 1 and 2 achieved objective response.

Posted

Mean

95% Confidence Interval

Weeks

From initial confirmed response (DR or PR) until PD or censored date. is defined as all participants who had not experienced the event of interest (i.e. ongoing, event free) at the time of the data cut off (used for the analysis).

ID	Title	Description
OG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 transduced cells
OG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells
OG002	Afamitresgene Autoleucel Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells
OG003	Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel

Secondary

Duration of Stable Disease (DoSD)

DoSD was defined as the time from the date of T-cell infusion to the first date of the radiological PD. This analysis of DoSD only applied to participants with BOR as confirmed CR, confirmed PR, or confirmed SD.

Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel

Posted

Median

95% Confidence Interval

Weeks

From date of afamitresgene autoleucel infusion to first date of radiological PD or censored date

ID	Title	Description
OG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 transduced cells
OG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells
OG002	Afamitresgene Autoleucel, Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells
OG003	Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel

Secondary

Progression Free Survival (PFS)

PFS was defined as the time from the date of the first T-cell infusion to the first date of the radiological PD or death date (due to any reason), whichever event was earlier.

Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel

Posted

Median

95% Confidence Interval

Weeks

From afamitresgene autoleucel infusion until first documented PD or death due to any cause, whichever comes first, or censored date.

ID	Title	Description
OG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 transduced cells
OG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells
OG002	Afamitresgene Autoleucel, Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells
OG003	Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel

Secondary

Overall Survival (OS)

OS was defined as the time from the date of afamitresgene autoleucel infusion to the date of death (due to any reason).

Posted

Median

95% Confidence Interval

Weeks

From afamitresgene autoleucel infusion until death due to any reason or censored date From afamitresgene autoleucel infusion until death due to any reason or censored date

ID	Title	Description
OG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 transduced cells
OG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells
OG002	Afamitresgene Autoleucel Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells
OG003	Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel	Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10^9 transduced cells).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cytokine release syndrome	Immune system disorders	Meddra V 23	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0028 affected32 at risk EG0030 affected4 at risk
Pneumonia	Infections and infestations	Meddra V 23	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Sepsis	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected32 at risk EG003
Anal abscess	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Cellulitis	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Endocarditis	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Endocarditis staphylococcal	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Rash pustular	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0023 affected32 at risk EG003
Aplastic anaemia	Blood and lymphatic system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Pyrexia	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0025 affected32 at risk EG003
Atrial fibrillation	Cardiac disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Aortic valve incompetence	Cardiac disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Arrhythmia	Cardiac disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Cardiac failure congestive	Cardiac disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Myocarditis	Cardiac disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Cerebrovascular accident	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Encephalopathy	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Neurotoxicity	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Sciatica	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Seizure	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Syncope	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Platelet count decreased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Alanine aminotransferase increased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Asparate aminotransferase increased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Blood alkaline phosphatase increased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Neutrophil count decreased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected32 at risk EG003
Laryngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected32 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Mental status change	Psychiatric disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Acute kidney injury	Renal and urinary disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Hypotension	Vascular disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Adrenal insufficiency	Endocrine disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphocyte count decreased	Investigations	Meddra V 23	Non-systematic Assessment	EG0003 affected3 at risk EG0013 affected3 at risk EG00231 affected32 at risk EG0034 affected4 at risk
White blood cell count decreased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0003 affected3 at risk EG0013 affected3 at risk EG00228 affected32 at risk EG003
Neutrophil count decreased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0003 affected3 at risk EG0013 affected3 at risk EG00227 affected32 at risk EG003
Platelet count decreased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0002 affected3 at risk EG0011 affected3 at risk EG00218 affected32 at risk EG003
Aspartate aminotransferase increased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0028 affected32 at risk EG003
Alanine aminotransferase increased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0027 affected32 at risk EG003
Blood creatinine increased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0024 affected32 at risk EG003
Nausea	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0003 affected3 at risk EG0012 affected3 at risk EG00219 affected32 at risk EG003
Vomiting	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0002 affected3 at risk EG0012 affected3 at risk EG00215 affected32 at risk EG003
Diarrhoea	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0002 affected3 at risk EG0010 affected3 at risk EG00212 affected32 at risk EG003
Constipation	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0012 affected3 at risk EG0024 affected32 at risk EG003
Fatigue	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0003 affected3 at risk EG0012 affected3 at risk EG00219 affected32 at risk EG003
Pyrexia	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0013 affected3 at risk EG00218 affected32 at risk EG003
Chills	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0028 affected32 at risk EG003
Oedema peripheral	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0012 affected3 at risk EG0024 affected32 at risk EG003
Malaise	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0024 affected32 at risk EG003
Non-cardiac chest pain	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0024 affected32 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0003 affected3 at risk EG0012 affected3 at risk EG00211 affected32 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0012 affected3 at risk EG00213 affected32 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0002 affected3 at risk EG0011 affected3 at risk EG0029 affected32 at risk EG003
Dehydration	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0026 affected32 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0024 affected32 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0023 affected32 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0023 affected32 at risk EG003
Anaemia	Blood and lymphatic system disorders	Medical Dictionary f	Non-systematic Assessment	EG0002 affected3 at risk EG0012 affected3 at risk EG00223 affected32 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0012 affected3 at risk EG0029 affected32 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0002 affected3 at risk EG0012 affected3 at risk EG00212 affected32 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0026 affected32 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0024 affected32 at risk EG003
Headache	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0013 affected3 at risk EG0027 affected32 at risk EG003
Dizziness	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0012 affected3 at risk EG0026 affected32 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0012 affected3 at risk EG0025 affected32 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0027 affected32 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0026 affected32 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0024 affected32 at risk EG003
Tachycardia	Cardiac disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0027 affected32 at risk EG003
Sinus tachycardia	Cardiac disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0012 affected3 at risk EG0024 affected32 at risk EG003
Atrial fibrillation	Cardiac disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0024 affected32 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0028 affected32 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0025 affected32 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0022 affected32 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0023 affected32 at risk EG003
Urinary tract infection	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0023 affected32 at risk EG003
Nasopharyngitis	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0024 affected32 at risk EG003
Hypotension	Vascular disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG00213 affected32 at risk EG003
Orthostatic hypotension	Vascular disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0024 affected32 at risk EG003
Cytokine release syndrome	Immune system disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG00220 affected32 at risk EG003
Insomnia	Psychiatric disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0025 affected32 at risk EG003
Acute kidney injury	Renal and urinary disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0024 affected32 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0028 affected32 at risk EG003
Blood alkaline phosphatase increased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Blood bilirubin increased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Weight decreased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Electocardiogram QT prolonged	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Troponin increased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Abdominal distention	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0022 affected32 at risk EG003
Dyspepsia	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Proctalgia	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Stomatitis	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Chest discomfort	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Drug withdrawal syndrome	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Face oedema	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected32 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	Meddra V 23	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Neutopenia	Blood and lymphatic system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0023 affected32 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Nasal congestion	Reproductive system and breast disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected32 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Meddra V 23	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0022 affected32 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Balance disorder	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected32 at risk EG003
Dysgeusia	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Hypoaesthesia	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Somnolence	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Night Sweats	Skin and subcutaneous tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Cystitis	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Pneumonia	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Sinusitis	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Upper respiratory tract infection	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Hypertension	Vascular disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Flushing	Vascular disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Confusional state	Psychiatric disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected32 at risk EG003
Anxiety	Psychiatric disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Haematuria	Renal and urinary disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0022 affected32 at risk EG003
Dysuria	Renal and urinary disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Contusion	Injury, poisoning and procedural complications	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Bradycardia	Cardiac disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Cancer Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Choking	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Cytomegalovirus viraemia	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Fall	Injury, poisoning and procedural complications	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Pain	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected32 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Rash morbilliform	Skin and subcutaneous tissue disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Restless leg syndrome	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Swelling face	General disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Troponin T increased	Investigations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Myocarditis	Cardiac disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Adrenal Insuffieiency	Endocrine disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003
Abdominal Pain	Gastrointestinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0002 affected3 at risk EG0012 affected3 at risk EG0027 affected32 at risk EG003
Sepsis	Infections and infestations	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected32 at risk EG003
Neurotoxicity	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected32 at risk EG003
Syncope	Nervous system disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Mental Status Changes	Psychiatric disorders	Medical Dictionary f	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected32 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Medical Dictionary f	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected32 at risk EG003

ID	Term
D001749	Urinary Bladder Neoplasms
D008545	Melanoma
D006258	Head and Neck Neoplasms
D010051	Ovarian Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung
D004938	Esophageal Neoplasms
D013274	Stomach Neoplasms
D013584	Sarcoma, Synovial
D018208	Liposarcoma, Myxoid
D009362	Neoplasm Metastasis
D000230	Adenocarcinoma
D012509	Sarcoma

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D004701	Endocrine Gland Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D005833	Genital Neoplasms, Female
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D004066	Digestive System Diseases
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D008080	Liposarcoma
D018205	Neoplasms, Adipose Tissue
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Afamitresgene Autoleucel, Group 1	Participants who received afamitresgene autoleucel 0.1x10^9 transduced cells	2	3	2	3	3	3
EG001	Afamitresgene Autoleucel, Group 2	Participants who received afamitresgene autoleucel 0.5-1.2x10^9 transduced cells	1	3	2	3	3	3
EG002	Afamitresgene Autoleucel, Group 3 + Expansion	Participants who received afamitresgene autoleucel 1.2-10x10^9 transduced cells	15	32	23	32	32	32
EG003	Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel	Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.	2	4	3	4	4	4