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 @ 2:11 PM
Ignite Modification Date: 2025-12-25 @ 12:51 PM
NCT ID: NCT02203695
Description: None
Frequency Threshold: 1
Time Frame: Up to 2 years
Study: NCT02203695
Study Brief: Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SRT Plus Enzalutamide Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT) Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT) 2 None 0 43 43 43 View
SRT Plus Placebo Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT) SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx 0 None 0 43 43 43 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nocturia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
erectile dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hypertension SYSTEMATIC_ASSESSMENT General disorders None View
fall SYSTEMATIC_ASSESSMENT General disorders None View
humerus fracture SYSTEMATIC_ASSESSMENT General disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
urinary frequency/urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
breast and nipple pain SYSTEMATIC_ASSESSMENT General disorders None View
sexuality alteration SYSTEMATIC_ASSESSMENT General disorders None View
urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
hemmorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hot flashes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pain (due to XRT) SYSTEMATIC_ASSESSMENT General disorders None View
Proctitis SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View