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 @ 1:20 PM
Ignite Modification Date:
2025-12-25 @ 12:26 PM
NCT ID:
NCT01327495
Description:
The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
Frequency Threshold:
0
Time Frame:
Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period.
Study:
NCT01327495
Study Brief:
PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm 1 | Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks placebo acyline: Placebo acyline subcutaneous injection every 2 weeks placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks | None | None | 0 | 10 | 7 | 10 | View |
| Arm 2 | Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks | None | None | 0 | 11 | 8 | 11 | View |
| Arm 3 | Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks | None | None | 0 | 10 | 6 | 10 | View |
| Arm 4 | Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks | None | None | 0 | 9 | 7 | 9 | View |
| Arm 5 | Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks | None | None | 0 | 11 | 10 | 11 | View |
| Arm 6 | Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks | None | None | 0 | 11 | 6 | 11 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Decreased libido | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Decreased energy, fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Erectile dysfunction | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Semen changes (decreased ejaculation volume | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Skin changes (acne, rash at site of T gel | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nipple discomfort | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Testicular pain | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Sexually transmitted disease | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea, vomiting, abnormal bowl movements | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Upper Respiratory infection/symptoms | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Musculoskeletal discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Injuries/accidents | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Blood in semen | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Bruise at injection site | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Abnormal liver funtion tests | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Allergic reaction to Acyline | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Discomfort at injection site | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hot flashes/night sweats | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mood changes (irritability) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Increased libido | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |