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 @ 7:41 PM
Ignite Modification Date: 2025-12-25 @ 5:20 PM
NCT ID: NCT01330303
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01330303
Study Brief: SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Product in Period 1; Reference Product in Period 2 Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2 None None 0 20 6 20 View
Reference Product in Period 1; Test Product in Period 2 Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2 None None 0 20 8 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Serum bilirubin increased (total and indirect) SYSTEMATIC_ASSESSMENT Investigations Ds Navigator View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Ds Navigator View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders Ds Navigator View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders Ds Navigator View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Ds Navigator View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Ds Navigator View
Serum urea increased SYSTEMATIC_ASSESSMENT Investigations Ds Navigator View
Postural hypotension SYSTEMATIC_ASSESSMENT Vascular disorders Ds Navigator View
Serum glutamic-pyruvic increased SYSTEMATIC_ASSESSMENT Investigations Ds Navigator View
Gamma glutamyl transferase increased SYSTEMATIC_ASSESSMENT Investigations Ds Navigator View
Glucose high SYSTEMATIC_ASSESSMENT Investigations Ds Navigator View
Serum triglycerides increased SYSTEMATIC_ASSESSMENT Investigations Ds Navigator View