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 @ 10:46 PM
Ignite Modification Date: 2025-12-25 @ 8:16 PM
NCT ID: NCT01370369
Description: The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
Frequency Threshold: 0
Time Frame: Overall Treatment Period (43 days)
Study: NCT01370369
Study Brief: Efficacy, Pharmacokinetics and Safety of Testosterone
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Testosterone 1.25 Subjects received testosterone gel 2% at dose of 1.25 mL (1 stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm. None None 0 20 1 20 View
Testosterone 2.50 Subjects received testosterone gel 2% at dose of 2.50 mL (2 strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm. None None 0 20 2 20 View
Testosterone 3.75 Subjects received testosterone gel 2% at dose of 3.75 mL (3 strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm. None None 0 20 2 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.1) View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.1) View
Prostatic specific antigen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.1) View
Nipple pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (10.1) View