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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:45 PM
NCT ID: NCT01266967
Description: SAEs and non-serious AEs were collected in the All Treated Subjects (ATS) Population, comprised of all participants who received at least one dose of study medication.
Frequency Threshold: 5
Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the time the first dose of study treatment was administered until 30 days following discontinuation of study treatment (up to 103 weeks).
Study: NCT01266967
Study Brief: A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GSK2118436 150 mg: Prior Local Therapy Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events. None None 31 83 74 83 View
GSK2118436 150 mg: No Prior Local Therapy Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events. None None 26 89 79 89 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Agranulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mobility decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Motor dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Viral pericarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Intracranial tumour haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Bowen's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Metastases to meninges SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Seborrhoeic keratosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Melanocytic naevus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Acrochordon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Actinic keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dysplastic naevus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Transient acantholytic dermatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hyperkeratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View