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: 2025-12-24 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:24 PM
NCT ID: NCT00419159
Description: None
Frequency Threshold: 5
Time Frame: Adverse events occurring up to 28 days after the discontinuation of study treatment.
Study: NCT00419159
Study Brief: Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Everolimus (RAD001) 10 mg/Day Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs. None None 22 100 98 100 View
Everolimus (RAD001) 70 mg/Week Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs. None None 34 99 99 99 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.X View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Malabsorption SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Cholangitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.X View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.X View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.X View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Central line infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Stent occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.X View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypercreatininaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Central nervous system lesion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Ureteric obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.X View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Hydropneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Respiratory alkalosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.X View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View