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 @ 10:21 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT04396535
Description: None
Frequency Threshold: 0
Time Frame: Up to 3 years and 2 months
Study: NCT04396535
Study Brief: Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung 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
Arm I (Docetaxel, Bintrafusp Alfa) Docetaxel: Given IV 0 None 0 6 3 6 View
Arm II (Docetaxel) Docetaxel: Given IV 1 None 1 3 1 3 View
Arm II Crossover (Docetaxel, Bintrafusp Alfa) Docetaxel: Given IV Docetaxel: Given IV 0 None 0 1 0 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disease progression SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 5 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 5 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Gastrointestinal disorders - Oth spec SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
ECG QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5 View