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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT02685267
Description: None
Frequency Threshold: 5
Time Frame: From treatment administration through 30 days after date of last dose
Study: NCT02685267
Study Brief: Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate 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
Docetaxel/Prednisone Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout Docetaxel Prednisone 3 None 2 5 5 5 View
Docetaxel/Prednisone + Enzalutamide Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel. Docetaxel Enzalutamide Prednisone 0 None 0 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Muscle weakness lower limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nail pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Watering eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Left great toe pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle weakness lower limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Generalized muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nail discoloration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin and subcutaneous tissue disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail loss NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bell's Palsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye infection NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Lacrimation NON_SYSTEMATIC_ASSESSMENT Eye disorders None View