Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:58 AM
NCT ID: NCT04889118
Description: The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Frequency Threshold: 5
Time Frame: Up to approximately 51 months
Study: NCT04889118
Study Brief: Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advanced Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)-China Extension Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pembrolizumab+Lenvatinib Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years. 49 None 14 64 64 64 View
Pembrolizumab + Placebo Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years. 47 None 12 67 66 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Traumatic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Paraneoplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Immune-mediated encephalitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Immune-mediated lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Gingival swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood bilirubin unconjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Electrocardiogram ST-T change SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Red blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Serum amyloid A protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Urinary occult blood positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Urobilinogen urine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
White blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Leukoderma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Skin depigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View