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 @ 11:58 AM
Ignite Modification Date: 2025-12-25 @ 11:56 AM
NCT ID: NCT02432261
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT02432261
Study Brief: Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1 5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders Nestorone® /testosterone gel: Nestorone® /testosterone combined gel 0 None 0 29 10 29 View
Group 2 4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders Testosterone only gel: Testosterone only gel 0 None 0 15 5 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
APPLICATION SITE RASH None General disorders None View
EXCORIATION None Injury, poisoning and procedural complications None View
SUNBURN None Injury, poisoning and procedural complications None View
BACK PAIN None Musculoskeletal and connective tissue disorders None View
HEADACE None Nervous system disorders None View
Varicocele None Reproductive system and breast disorders None View
DIARRHEA None General disorders None View
VOMITING None Gastrointestinal disorders None View
HYPERSENSITIVITY None Immune system disorders None View
LOCALIZED INFECTION None Infections and infestations None View
LIGAMENT SPRAIN None Injury, poisoning and procedural complications None View
Periorbital contusion None Injury, poisoning and procedural complications None View
THERMAL BURN None Injury, poisoning and procedural complications None View
Eosinophil count increased None Investigations None View
PAIN IN EXTREMITY None Metabolism and nutrition disorders None View
CONVULSION None Nervous system disorders None View
SYNCOPE None Nervous system disorders None View
LIBIDO DECREASED None Psychiatric disorders None View
DRY SKIN None Skin and subcutaneous tissue disorders None View