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:
NCT02159469
Description:
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
In total, 125 (83.3%) patients had TEAEs during the study.
Frequency Threshold:
2
Time Frame:
Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 weeks
Study:
NCT02159469
Study Brief:
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
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 Enanthate Auto-injector | Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study. Testosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg | 1 | None | 3 | 150 | 125 | 150 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematocrit increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Prostatic specific antigen increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Blood testosterone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Injection site hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Edema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Sleep apnea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 10.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 10.0 | View |
| Polycythemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.0 | View |