Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:47 PM
NCT ID: NCT01136967
Description: None
Frequency Threshold: 5
Time Frame: From date of administration of first dose up to 30 days after the last dose, or up to data cutoff (15 Jan 2012 and 15 Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 33 months.
Study: NCT01136967
Study Brief: An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 (V600E BRAF Negative) Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles. None None 39 93 93 93 View
Cohort 2 (V600E BRAF Positive) Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles. None None 36 89 88 89 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Cranial nerve palsies multiple SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Infected neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Select View
Metastatic pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Select View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders Select View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders Select View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Select View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Select View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Select View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Select View
Gallbladder perforation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Select View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Select View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Select View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Select View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations Select View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations Select View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Select View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Select View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Select View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Select View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Select View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Select View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders Select View
Fatigue SYSTEMATIC_ASSESSMENT General disorders Select View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders Select View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders Select View
Pain SYSTEMATIC_ASSESSMENT General disorders Select View
Chemical peritonitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Select View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Select View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Select View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders Select View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders Select View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders Select View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders Select View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders Select View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Oesophageal spasm SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Rectal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Catheter site infection SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Incision site infection SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Pelvic abscess SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders Select View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders Select View
Urethral obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders Select View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders Select View
Atrial thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders Select View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders Select View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders Select View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders Select View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders Select View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders Select View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Select View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Select View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Select View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations Select View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders Select View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Select View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Select View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders Select View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Glossodynia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Select View
Asthenia SYSTEMATIC_ASSESSMENT General disorders Select View
Chills SYSTEMATIC_ASSESSMENT General disorders Select View
Fatigue SYSTEMATIC_ASSESSMENT General disorders Select View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders Select View
Pain SYSTEMATIC_ASSESSMENT General disorders Select View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders Select View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations Select View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations Select View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations Select View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations Select View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations Select View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations Select View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations Select View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Select View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Select View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Select View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Select View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Select View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders Select View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders Select View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders Select View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders Select View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders Select View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders Select View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Select View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Select View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Select View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Select View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Select View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Select View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Select View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Select View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders Select View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders Select View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders Select View