Premedication to Reduce Amivantamab Associated Infusion R... | NCT05663866

ID	Type	Description
61186372NSC2005	Other Identifier	Janssen Research & Development, LLC
2022-000974-25	EudraCT Number
2023-506578-11-00	Registry Identifier	EUCT number

Status Module

Label	Type	Description	Intervention Names
Background Anti-cancer Therapy with Amivantamab Plus Lazertinib	Experimental	Participant will receive following treatments in 4 different cohorts prior to administration of combination therapy of IV Amivantamab and oral Lazertinib (anti-cancer regimen): dexamethasone dose-1 in Cohort A; dexamethasone dose-2 in Cohort A2; montelukast in Cohort B; and methotrexate in Cohort C.	Drug: Dexamethasone Drug: Montelukast Drug: Methotrexate Drug: Amivantamab Drug: Lazertinib

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	Dexamethasone will be administered orally.	Background Anti-cancer Therapy with Amivantamab Plus Lazertinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1	Percentage of participants with IRRs at Cycle 1 Day 1 was reported. IRRs were defined as IRR events with onset time within 24 hours of the start of the first amivantamab infusion and prior to the start of amivantamab infusion on Cycle 1 Day 2. IRR included chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever. IRRs that occurred on Cycle 1 Day 2 pre-infusion were considered under Cycle 1 Day 1.	Cycle 1 Day 1 (each cycle of 28 days)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Adverse Events of Infusion-related Reactions (IRRs) During Cycle 1 Day 1		Cycle 1 Day 1 (each cycle of 28 days)
Percentage of Participants With Adverse Events (AEs) of Infusion-related Reactions (IRRs) as Per Severity up to End of Cycle 3 (Cycle 3 Day 28)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant must have advanced or metastatic non-small cell lung cancer (NSCLC)
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
A female participant using oral contraceptives must use an additional barrier contraceptive method
A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 3 months after receiving the last dose of study treatment, oral lazertinib and intravenous (IV) Amivantamab
Each participant, or legally authorized representative, where allowed, must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Progressed on or after prior treatment with osimertinib and platinum-based chemotherapy. Prior use of first-or-second generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) is allowed if administered prior to osimertinib
Previously identified EGFR-mutated non-small cell lung cancer (NSCLC) (EGFR Exon19 deletion or L858R) (identified locally in a Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory [or equivalent])

Exclusion Criteria:

Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
Prior treatment with anti PD-1 or anti PD-L1 antibody within 6 weeks of planned first dose of study treatment or immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment
Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment are allowed. If brain metastases are diagnosed on Screening imaging, the participant may be enrolled, or rescreened for eligibility, after definitive treatment if above criteria are met
Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to [<=] 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement therapy)
Prior treatment with amivantamab or lazertinib

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Compassionate Cancer Care		Fountain Valley	California	92708	United States
Virginia Cancer Specialists

PubMed Identifier	Type	Citation	Retractions
39864547	Derived	Spira AI, Paz-Ares L, Han JY, Shih JY, Mascaux C, Roy UB, Zugazagoitia J, Kim YJ, Chiu CH, Kim SW, Nadal E, Gil-Bazo I, Murphy SP, Anderson BG, Xia Y, Wang G, Bauml JM, Chioda M, Simoes J, Mahadevia PJ, Lopes G. Preventing Infusion-Related Reactions With Intravenous Amivantamab-Results From SKIPPirr, a Phase 2 Study: A Brief Report. J Thorac Oncol. 2025 Jun;20(6):809-816. doi: 10.1016/j.jtho.2025.01.018. Epub 2025 Jan 24.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort A: Dexamethasone 4 Milligrams (mg)	Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than [<] 80 kilograms [kg]) or 1400 mg (for participants greater than or equal to [>=] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.

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	Yes	No	No	Study Protocol	Aug 21, 2023	Oct 3, 2025

Arm/Group Information

ID	Title	Description
BG000	Cohort A: Dexamethasone 4 Milligrams (mg)	Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than [<] 80 kilograms [kg]) or 1400 mg (for participants greater than or equal to [>=] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
BG001	Cohort A2: Dexamethasone 8 mg	Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants <80 kg) or 1400 mg (for participants >=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
BG002	Cohort B: Montelukast 10 mg	Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants <80 kg) or 1400 mg (for participants >=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
BG003	Cohort C: Methotrexate 25 mg	Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants <80 kg) or 1400 mg (for participants >=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
BG004	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

Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1

Percentage of participants with IRRs at Cycle 1 Day 1 was reported. IRRs were defined as IRR events with onset time within 24 hours of the start of the first amivantamab infusion and prior to the start of amivantamab infusion on Cycle 1 Day 2. IRR included chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever. IRRs that occurred on Cycle 1 Day 2 pre-infusion were considered under Cycle 1 Day 1.

The per protocol analysis set included all participants who had received all prophylaxis treatment based on schedule and had received the administration of amivantamab and lazertinib on Cycle 1 Day 1.

Posted

Number

95% Confidence Interval

Percentage of participants

Cycle 1 Day 1 (each cycle of 28 days)

ID	Title	Description
OG000	Cohort A: Dexamethasone 4 Milligrams (mg)	Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than [<] 80 kilograms [kg]) or 1400 mg (for participants greater than or equal to [>=] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
OG001	Cohort A2: Dexamethasone 8 mg	Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants <80 kg) or 1400 mg (for participants >=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
OG002	Cohort B: Montelukast 10 mg	Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants <80 kg) or 1400 mg (for participants >=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.
OG003	Cohort C: Methotrexate 25 mg	Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants <80 kg) or 1400 mg (for participants >=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.

Units	Counts
Participants	OG0006 OG00140 OG00215 OG003

Title

Denominators

Categories

Title	Measurements
	OG00083.3(35.9 to 99.6) OG00122.5(10.8 to 38.5) OG00266.7(38.4 to 88.2) OG003

Secondary

Percentage of Participants With Adverse Events of Infusion-related Reactions (IRRs) During Cycle 1 Day 1

Not Posted

Jul 2027

Cycle 1 Day 1 (each cycle of 28 days)

Participants

Secondary

Percentage of Participants With Adverse Events (AEs) of Infusion-related Reactions (IRRs) as Per Severity up to End of Cycle 3 (Cycle 3 Day 28)

Not Posted

Jul 2027

From Cycle 1 Day 1 up to Cycle 3 Day 28 (each cycle of 28 days)

Participants

Secondary

Percentage of Participants With IRRs up to End of Treatment (EOT)

Not Posted

Jul 2027

From Cycle 1 Day 1 (each cycle of 28 days) up to 27.3 months

Participants

Secondary

Percentage of Participants With Other Adverse Events (AEs): Non-IRRs

Not Posted

Jul 2027

From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months

Participants

Secondary

Duration of Infusion Time for Pre-amivantamab Infusion Medications, IV Amivantamab Infusion, and Post-amivantamab Infusion Medications on Cycle 1 Day 1

Not Posted

Jul 2027

Cycle 1 Day 1 (each cycle of 28 days)

Participants

Secondary

Percentage of Participants Completing Amivantamab Infusion Within 4 Hours on Cycle 1 Day 1

Not Posted

Jul 2027

Up to 4 hours on Cycle 1 Day 1 (each cycle of 28 days)

Participants

Secondary

Overall Response Rate (ORR)

Not Posted

Jul 2027

From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months

Participants

Secondary

Duration of Response (DOR)

Not Posted

Jul 2027

From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months

Participants

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	Cohort A1: Dexamethasone 4 Milligrams (mg)	Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than [<] 80 kilograms [kg]) or 1400 mg (for participants greater than or equal to [>=] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.	0	6	2	6	6	6
EG001	Cohort A2: Dexamethasone 8 mg	Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants <80 kg) or 1400 mg (for participants >=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.	4	41	20	41	41	41
EG002	Cohort B: Montelukast 10 mg	Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants <80 kg) or 1400 mg (for participants >=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.	2	15	5	15	15	15
EG003	Cohort C: Methotrexate 25 mg	Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants <80 kg) or 1400 mg (for participants >=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.	0	6	2	6	6	6

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected41 at risk EG0020 affected15 at risk EG0030 affected6 at risk
Cellulitis	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Empyema	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Pneumonia Aspiration	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Pneumonia Bacterial	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Respiratory Tract Infection	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Skin Infection	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Subcutaneous Abscess	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0021 affected15 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Pyrexia	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0022 affected15 at risk EG003
Fatigue	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Spinal Cord Compression	Nervous system disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected41 at risk EG0020 affected15 at risk EG003
Cerebral Infarction	Nervous system disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Osteoporotic Fracture	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Femur Fracture	Injury, poisoning and procedural complications	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Abnormal Behaviour	Psychiatric disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Hypotension	Vascular disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0002 affected6 at risk EG00117 affected41 at risk EG0028 affected15 at risk EG0033 affected6 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0002 affected6 at risk EG0015 affected41 at risk EG0023 affected15 at risk EG003
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0002 affected6 at risk EG0017 affected41 at risk EG0023 affected15 at risk EG003
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0016 affected41 at risk EG0023 affected15 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0002 affected6 at risk EG0014 affected41 at risk EG0020 affected15 at risk EG003
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected41 at risk EG0021 affected15 at risk EG003
Skin Fissures	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected41 at risk EG0020 affected15 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected41 at risk EG0021 affected15 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0022 affected15 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0021 affected15 at risk EG003
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Seborrhoeic Dermatitis	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Xeroderma	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0021 affected15 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Rash Erythematous	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Skin Necrosis	Skin and subcutaneous tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0002 affected6 at risk EG00110 affected41 at risk EG0026 affected15 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG00114 affected41 at risk EG0023 affected15 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0002 affected6 at risk EG0018 affected41 at risk EG0021 affected15 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0017 affected41 at risk EG0022 affected15 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0015 affected41 at risk EG0022 affected15 at risk EG003
Gingival Bleeding	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected41 at risk EG0022 affected15 at risk EG003
Mouth Ulceration	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected41 at risk EG0021 affected15 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0022 affected15 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected41 at risk EG0020 affected15 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0021 affected15 at risk EG003
Gastric Ulcer	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Mouth Haemorrhage	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Paronychia	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0002 affected6 at risk EG00116 affected41 at risk EG00210 affected15 at risk EG003
Covid-19	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0025 affected15 at risk EG003
Folliculitis	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected41 at risk EG0023 affected15 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected41 at risk EG0021 affected15 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected41 at risk EG0020 affected15 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Sinusitis	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0022 affected15 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Eye Infection	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Gingivitis	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Influenza	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Rash Pustular	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Respiratory Tract Infection	Infections and infestations	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Oedema Peripheral	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0019 affected41 at risk EG0025 affected15 at risk EG003
Asthenia	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0002 affected6 at risk EG0017 affected41 at risk EG0023 affected15 at risk EG003
Chills	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected41 at risk EG0026 affected15 at risk EG003
Chest Discomfort	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0022 affected15 at risk EG003
Fatigue	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected41 at risk EG0023 affected15 at risk EG003
Pyrexia	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected41 at risk EG0022 affected15 at risk EG003
Malaise	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected41 at risk EG0021 affected15 at risk EG003
Infusion Site Extravasation	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0021 affected15 at risk EG003
Feeling Hot	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Lithiasis	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Localised Oedema	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Non-Cardiac Chest Pain	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Temperature Regulation Disorder	General disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0019 affected41 at risk EG0023 affected15 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0002 affected6 at risk EG0017 affected41 at risk EG0021 affected15 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected41 at risk EG0025 affected15 at risk EG003
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected41 at risk EG0020 affected15 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected41 at risk EG0022 affected15 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0022 affected15 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0022 affected15 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0021 affected15 at risk EG003
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Laryngeal Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Throat Irritation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG00117 affected41 at risk EG0024 affected15 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0014 affected41 at risk EG0024 affected15 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0018 affected41 at risk EG0024 affected15 at risk EG003
Headache	Nervous system disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0018 affected41 at risk EG0021 affected15 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected41 at risk EG0022 affected15 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected41 at risk EG0022 affected15 at risk EG003
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected41 at risk EG0021 affected15 at risk EG003
Petit Mal Epilepsy	Nervous system disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Tremor	Nervous system disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0015 affected41 at risk EG0023 affected15 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0015 affected41 at risk EG0022 affected15 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected41 at risk EG0021 affected15 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected41 at risk EG0020 affected15 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0022 affected15 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Hypotension	Vascular disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0018 affected41 at risk EG0020 affected15 at risk EG003
Flushing	Vascular disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected41 at risk EG0022 affected15 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0002 affected6 at risk EG0011 affected41 at risk EG0020 affected15 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Orthostatic Hypotension	Vascular disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Venous Thrombosis	Vascular disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0015 affected41 at risk EG0022 affected15 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0015 affected41 at risk EG0022 affected15 at risk EG003
Blood Creatine Phosphokinase Increased	Investigations	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected41 at risk EG0020 affected15 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0022 affected15 at risk EG003
Blood Creatinine Increased	Investigations	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Blood Creatine Increased	Investigations	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected41 at risk EG0020 affected15 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected41 at risk EG0021 affected15 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0015 affected41 at risk EG0021 affected15 at risk EG003
Dry Eye	Eye disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected41 at risk EG0021 affected15 at risk EG003
Trichiasis	Eye disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Eye Pain	Eye disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Limb Injury	Injury, poisoning and procedural complications	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0021 affected15 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0022 affected15 at risk EG003
Sinus Tachycardia	Cardiac disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected41 at risk EG0021 affected15 at risk EG003
Ear Inflammation	Ear and labyrinth disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Renal Failure	Renal and urinary disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003
Genital Rash	Reproductive system and breast disorders	MedDRA Version 26.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected41 at risk EG0021 affected15 at risk EG003

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Term
D003907	Dexamethasone
C093875	montelukast
D008727	Methotrexate
C000718215	amivantamab
C000707992	lazertinib