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 @ 3:37 PM
Ignite Modification Date: 2025-12-25 @ 1:49 PM
NCT ID: NCT01215292
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01215292
Study Brief: ITT4 Intratesticular Hormonal Milieu in Man (ITT4)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Acyline & T Gel & Ketoconazole 400 Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10 None None 1 8 3 8 View
Acyline & T Gel & Dutasteride Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10 None None 0 8 2 8 View
Acyline & T Gel & Placebo Ketoconazole Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10 None None 0 8 5 8 View
Acyline & T Gel & Ketoconazole 800 Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10 None None 0 8 6 8 View
Group 5: Anastrazole Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10 None None 0 8 5 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Testicular hematoma and hematocele NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abdomenal ecchymosis SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (10.0) View
Change in mood/irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Decreased libido SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Finger laceration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Pain at spermatic cord/at scrotum NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (10.0) View
platar fascitis NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (10.0) View
Prostatitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (10.0) View
Seasonal allergies NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
pruritus/rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View