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 @ 4:12 AM
Ignite Modification Date: 2025-12-26 @ 3:11 AM
NCT ID: NCT00224120
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00224120
Study Brief: A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Silodosin Silodosin 8 mg once daily with food None None 3 233 99 233 View
Placebo Matching placebo capsule once daily with food None None 4 229 15 229 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Enterocolitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lesion excision NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Atrioventricular block third degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Retrograde ejaculation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Prostatic specific antigen increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View