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 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 10:14 PM
NCT ID: NCT01607658
Description: None
Frequency Threshold: 3
Time Frame: 84 days
Study: NCT01607658
Study Brief: Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event Placebo: placebo intranasal gel administered prn, 2-8 hours before a planned sexual event 0 None 0 65 24 65 View
Low Dose TBS-2 Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn Low dose TBS-2: Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event 0 None 0 67 35 67 View
Medium Dose TBS-2 Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn Medium dose TBS-2: Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event 0 None 0 58 20 58 View
High Dose TBS-2 High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn High dose TBS-2: High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event 0 None 0 63 38 63 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasal Inflamation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Mucosal Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hair Growth Abnormal SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hirsutism SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scab SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urine Analysis Abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View