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 @ 2:42 AM
Ignite Modification Date: 2025-12-26 @ 1:21 AM
NCT ID: NCT01924533
Description: Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Frequency Threshold: 5
Time Frame: None
Study: NCT01924533
Study Brief: Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2 181 None 92 262 257 262 View
Placebo Tablets bd + Paclitaxel 80 mg/m^2 Placebo tablets bd + Paclitaxel 80 mg/m\^2 200 None 65 259 253 259 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stent malfunction SYSTEMATIC_ASSESSMENT Product Issues MedDRA 19.0 View
Device malfunction SYSTEMATIC_ASSESSMENT Product Issues MedDRA 19.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Bone marrow disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Intestinal dilatation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Oesophageal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Cholangitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Dilatation intrahepatic duct acquired SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Atypical mycobacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Scrub typhus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Gastrointestinal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Splenic rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Coagulation test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Granulocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypoproteinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Optic neuritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Chylothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View