Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-26 @ 10:44 PM
Ignite Modification Date: 2025-12-26 @ 10:44 PM
NCT ID: NCT00924612
Description: Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
Frequency Threshold: 0
Time Frame: 3 months
Study: NCT00924612
Study Brief: Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fasting Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state Oral testosterone undecanoate (containing 300 mg T) 0 None 0 16 2 16 View
Very Low Fat Diet Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with very low fat (6-10% fat). Oral testosterone undecanoate (containing 300 mg T) 0 None 0 16 0 16 View
Low Fat Diet Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with low fat (20% fat). Oral testosterone undecanoate (containing 300 mg T) 0 None 0 16 2 16 View
Normal Diet Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with normal fat (30% fat). Oral testosterone undecanoate (containing 300 mg T) 0 None 0 16 4 16 View
High Fat Diet Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with high fat (50% fat). Oral testosterone undecanoate (containing 300 mg T) 0 None 0 16 3 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Otopharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View