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: 2025-12-26 @ 1:18 PM
Ignite Modification Date: 2025-12-26 @ 1:18 PM
NCT ID: NCT00975806
Description: Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
Frequency Threshold: 5
Time Frame: Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued.
Study: NCT00975806
Study Brief: Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma
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 A Lenalidomide 10 mg QD and sunitinib 37.5 mg QD on Days 1-21 of each 21-day cycle None None 3 5 5 5 View
Cohort F Lenalidomide 10 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle None None 4 7 7 7 View
Cohort G Lenalidomide 15 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle None None 2 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
General Physical Health Deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Seasonal Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 14.0 View
Infected Bites SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Post Procedural Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Transaminases Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Blood Lactate Dehydrogenase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
White Blood Cell Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Blood Alkaline Phosphatase SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Decreasd Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Neuropathy Peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Haemoglobinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Scrotal Oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Orophryngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hair Colour Changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Rash Maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Scar Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Night Sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper Respiratory Tract Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sputum Discoloured SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Periorbital oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Tear discolouration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Glossodynia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Tongue Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Tongue Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Non-cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Early Satiety SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Face Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Thrombocytpenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Haemogloinaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Splinter Haemorrhages SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 14.0 View
Thyroiditis Subacute SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 14.0 View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye Swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View