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 @ 7:40 PM
Ignite Modification Date: 2025-12-25 @ 5:20 PM
NCT ID: NCT03366103
Description: None
Frequency Threshold: 5
Time Frame: Up to 1.5 years
Study: NCT03366103
Study Brief: Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other 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
Phase 1 - Dose Level 1 Navitoclax 150 mg po qd + Vistusertib 35 mg po bid 6 None 2 9 9 9 View
Phase 1 - Dose Level 2 Navitoclax 250 mg po qd + Vistusertib 35 mg po bid 3 None 2 5 5 5 View
Phase 2 Navitoclax 150 mg po qd + Vistusertib 35 mg po bid 1 None 0 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood bilirubin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Frequent stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loose stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thrush SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Sweating SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
INR increased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cramping SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Renal and urinary disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Progressive Disease SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View