Study of Pemetrexed+Platinum Chemotherapy With or Without... | NCT04786964

Label	Type	Description	Intervention Names
Cosibelimab	Experimental	Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression.	Drug: Cosibelimab Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed Dietary Supplement: Folic acid 350-1000 μg Dietary Supplement: Vitamin B12 1000 μg Drug: Dexamethasone 4mg
Control	Active Comparator	Participants receive pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pemetrexed 500 mg/m^2 IV Q3W until progression.	Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed Dietary Supplement: Folic acid 350-1000 μg Dietary Supplement: Vitamin B12 1000 μg Drug: Dexamethasone 4mg

Name	Type	Description	Arm Group Labels	Other Names
Cosibelimab	Drug	IV infusion	Cosibelimab
Cisplatin

Measure	Description	Time Frame
Overall Survival (OS)	Defined as the time from randomization to death due to any cause.	Approximately 3 years.

Measure	Description	Time Frame
Progression-Free Survival (PFS)	Defined as the time from randomization until disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).	Approximately 3 years.
Objective Response Rate (ORR)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated.
Has measurable disease.
Has not received prior systemic treatment for their advanced/metastatic NSCLC.
Can provide tumor tissue.
Has a life expectancy of at least 3 months.
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
Has adequate organ function
If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 180 days after the last dose of study medication and chemotherapeutic agents.

Exclusion Criteria:

Has predominantly squamous cell histology NSCLC.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of study medication.
Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab), c) Had major surgery (<3 weeks prior to first dose).
Received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study medication.
Completed palliative radiotherapy within 7 days of the first dose of study medication.
Is expected to require any other form of antineoplastic therapy while on study.
Received a live-virus vaccination within 30 days of planned start of study medication.
Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, peritoneal carcinomatosis.
Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb).
Known sensitivity to any component of cisplatin, carboplatin or pemetrexed.
Has active autoimmune disease that has required systemic treatment in past 2 years.
Is on chronic systemic steroids.
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
Is unable or unwilling to take folic acid or vitamin B12 supplementation.
Had prior treatment with any other anti-programmed cell death-1 (PD-1), or PD-ligand 1 (PD-L1) or PD-L2 agent or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
Has an active infection requiring therapy.
Has known history of Human Immunodeficiency Virus (HIV).
Has known active Hepatitis B or C.
Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
Is a known regular user of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
Has symptomatic ascites or pleural effusion.
Has active or history of interstitial lung disease or a history of (non infectious) pneumonitis that required steroids or current pneumonitis.
Has had an allogeneic tissue/solid organ transplant.
Any known uncontrolled or significant cardiovascular disease.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Vitória			Brazil
Research Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cosibelimab	Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion Folic acid 350-1000 μg: Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Vitamin B12 1000 μg: Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 12, 2021

Arm/Group Information

ID	Title	Description
BG000	Cosibelimab	Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion Folic acid 350-1000 μg: Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Vitamin B12 1000 μg: Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
BG001	Control	Participants receive pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pemetrexed 500 mg/m^2 IV Q3W until progression. Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion Folic acid 350-1000 μg: Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Vitamin B12 1000 μg: Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
BG002	Total	Total of all reporting groups

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

Overall Survival (OS)

Defined as the time from randomization to death due to any cause.

Due to the Russia/Ukraine conflict initiating during the study start up, the study was put on hold, and then the study terminated prior to efficacy analysis. This study will not be used to support marketing application approval.

Posted

Approximately 3 years.

ID	Title	Description
OG000	Cosibelimab	Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion Folic acid 350-1000 μg: Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Vitamin B12 1000 μg: Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
OG001	Control	Participants receive pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pemetrexed 500 mg/m^2 IV Q3W until progression. Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion Folic acid 350-1000 μg: Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Vitamin B12 1000 μg: Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.

Units	Counts
Participants	OG0000 OG0010

Secondary

Progression-Free Survival (PFS)

Defined as the time from randomization until disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Posted

Approximately 3 years.

ID	Title	Description
OG000	Cosibelimab	Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion Folic acid 350-1000 μg: Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Vitamin B12 1000 μg: Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
OG001	Control

Secondary

Objective Response Rate (ORR)

Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1

Posted

Approximately 3 years.

ID	Title	Description
OG000	Cosibelimab	Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion Folic acid 350-1000 μg: Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Vitamin B12 1000 μg: Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
OG001	Control

Secondary

Duration of Response (DOR)

Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1) or death from any cause, whichever comes first.

Posted

Approximately 3 years.

ID	Title	Description
OG000	Cosibelimab	Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion Folic acid 350-1000 μg: Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Vitamin B12 1000 μg: Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
OG001	Control

Secondary

Number of Participants Who Experienced an Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a study participant administered study drug and which does not necessarily have to have a causal relationship with this study drug.

Adverse event monitoring was performed throughout the study; after the end of treatment, subjects were followed for a minimum of 30 days for AE monitoring through the end of the study, which was up to 2 years.

Posted

Count of Participants

Participants

Approximately 2 years.

ID	Title	Description
OG000	Cosibelimab	Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion Folic acid 350-1000 μg: Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Vitamin B12 1000 μg: Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cosibelimab	Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. Cosibelimab: IV infusion Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion Folic acid 350-1000 μg: Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Vitamin B12 1000 μg: Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.	1	19	2	19	14	19
EG001	Control	Participants receive pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pemetrexed 500 mg/m^2 IV Q3W until progression. Cisplatin: IV infusion Carboplatin: IV infusion Pemetrexed: IV infusion Folic acid 350-1000 μg: Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. Vitamin B12 1000 μg: Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. Dexamethasone 4mg: For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.	0	6	1	6	6	6

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Asthenia	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected19 at risk EG0011 affected6 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0008 affected19 at risk EG0010 affected6 at risk
Anemia	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0006 affected19 at risk EG0013 affected6 at risk
Decreased appetite	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0003 affected19 at risk EG0011 affected6 at risk
Other abnormal labs	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0007 affected19 at risk EG0014 affected6 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected19 at risk EG0010 affected6 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0011 affected6 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0013 affected6 at risk
Immune-mediated thyroiditis	Endocrine disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected19 at risk EG0010 affected6 at risk
Fatigue	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected19 at risk EG0010 affected6 at risk
Non-cardiac chest pain	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected19 at risk EG0010 affected6 at risk
Pyrexia	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Type I hypersensitivity	Immune system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Cystitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0011 affected6 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected19 at risk EG0010 affected6 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0011 affected6 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected19 at risk EG0010 affected6 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Chest wall cyst	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected19 at risk EG0010 affected6 at risk
Headache	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected19 at risk EG0010 affected6 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected19 at risk EG0010 affected6 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected19 at risk EG0010 affected6 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0011 affected6 at risk
Prostate calcifications	Reproductive system and breast disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0011 affected6 at risk
Edema	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0012 affected6 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0012 affected6 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0012 affected6 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0011 affected6 at risk
Hypotonia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0011 affected6 at risk
Vascular leukoencephalopathy	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0011 affected6 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0011 affected6 at risk
COVID-19	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0011 affected6 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0011 affected6 at risk
Hydrocephalus	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0011 affected6 at risk
Influenza	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected19 at risk EG0011 affected6 at risk

ID	Term
D009362	Neoplasm Metastasis
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D002945	Cisplatin
D016190	Carboplatin
D000068437	Pemetrexed
D005492	Folic Acid
D014805	Vitamin B 12
D003907	Dexamethasone

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic
D011622	Pterins
D011621	Pteridines
D045728	Corrinoids
D045725	Tetrapyrroles
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006576	Heterocyclic Compounds, 4 or More Rings
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D013259	Steroids, Fluorinated

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected6 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected6 at risk
COVID-19	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected6 at risk