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 @ 1:07 AM
Ignite Modification Date: 2025-12-25 @ 11:19 PM
NCT ID: NCT02457793
Description: None
Frequency Threshold: 5
Time Frame: 15 months
Study: NCT02457793
Study Brief: A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Not Assigned One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration. None None 1 1 1 1 View
COB 20 mg + GDC 200 mg Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. None None 2 5 5 5 View
COB 40 mg + GDC 200 mg Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. None None 2 3 3 3 View
COB 80 mg + GDC 200 mg Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. None None 3 5 5 5 View
COB 80 mg + GDC 400 mg Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off. None None 2 4 4 4 View
COB 100 mg + GDC 200 mg Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. None None 4 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
COLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
GASTRIC ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
CHOLANGITIS INFECTIVE SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
CLOSTRIDIUM DIFFICILE COLITIS SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
KLEBSIELLA BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
PNEUMONIA VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
DISEASE PROGRESSION SYSTEMATIC_ASSESSMENT General disorders 19.1 View
GAIT DISTURBANCE SYSTEMATIC_ASSESSMENT General disorders 19.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders 19.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders 19.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
HYPOXIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 19.1 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 19.1 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 19.1 View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
ASCITES SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
COLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
HAEMATOCHEZIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
SALIVARY GLAND ENLARGEMENT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders 19.1 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders 19.1 View
FACE OEDEMA SYSTEMATIC_ASSESSMENT General disorders 19.1 View
GENERALISED OEDEMA SYSTEMATIC_ASSESSMENT General disorders 19.1 View
LOCALISED OEDEMA SYSTEMATIC_ASSESSMENT General disorders 19.1 View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders 19.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders 19.1 View
PERIPHERAL SWELLING SYSTEMATIC_ASSESSMENT General disorders 19.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders 19.1 View
ATYPICAL PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
VULVOVAGINAL MYCOTIC INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
LACERATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
BLOOD ALBUMIN DECREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
BLOOD ALKALINE PHOSPHATASE INCREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
BLOOD BILIRUBIN INCREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
BLOOD LACTATE DEHYDROGENASE INCREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
EJECTION FRACTION DECREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
GAMMA-GLUTAMYLTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
PLATELET COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
PROTEIN TOTAL DECREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
TROPONIN INCREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
WHITE BLOOD CELL COUNT INCREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
HYPERKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
HYPOALBUMINAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
HYPOCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
HYPOMAGNESAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
HYPOPHOSPHATAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
HYPOVOLAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
MALNUTRITION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
ATAXIA SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
BURNING SENSATION SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
PRESYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
VISUAL FIELD DEFECT SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
CONFUSIONAL STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders 19.1 View
DELIRIUM SYSTEMATIC_ASSESSMENT Psychiatric disorders 19.1 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders 19.1 View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders 19.1 View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders 19.1 View
HAEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders 19.1 View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders 19.1 View
ALVEOLAR LUNG DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
DYSPHONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
PNEUMONITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
PULMONARY HYPERTENSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
PULMONARY OEDEMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
SINUS CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
TONSILLAR HYPERTROPHY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
DERMATITIS ACNEIFORM SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
PAIN OF SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
RASH MACULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
RASH MACULO-PAPULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
RASH PRURITIC SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
SWELLING FACE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
BLOOD LACTIC ACID INCREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
BLOOD UREA INCREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
DEEP VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders 19.1 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders 19.1 View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders 19.1 View
LEFT VENTRICULAR DYSFUNCTION SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
SINUS BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
SINUS TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
DYSACUSIS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders 19.1 View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders 19.1 View
ADRENAL INSUFFICIENCY SYSTEMATIC_ASSESSMENT Endocrine disorders 19.1 View
DETACHMENT OF RETINAL PIGMENT EPITHELIUM SYSTEMATIC_ASSESSMENT Eye disorders 19.1 View
EYELID OEDEMA SYSTEMATIC_ASSESSMENT Eye disorders 19.1 View
PERIORBITAL OEDEMA SYSTEMATIC_ASSESSMENT Eye disorders 19.1 View
PHOTOPHOBIA SYSTEMATIC_ASSESSMENT Eye disorders 19.1 View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders 19.1 View
VISUAL IMPAIRMENT SYSTEMATIC_ASSESSMENT Eye disorders 19.1 View
VITREOUS FLOATERS SYSTEMATIC_ASSESSMENT Eye disorders 19.1 View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
ABDOMINAL PAIN LOWER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders 19.1 View
CANDIDA INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations 19.1 View