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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
NCT ID:
NCT02222558
Description:
An AE could have been any unfavorable and unintended sign, symptom. Subjects were asked a question "How have you been feeling since you were last asked?" at all visits from Day 0 to Exit.
Each sign or symptom was graded on a 3-point scale (mild, moderate, or severe).
Frequency Threshold:
5
Time Frame:
17 September 2014 (first subject Day 0) to 23 April 2015 (last subject visit). Adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
Study:
NCT02222558
Study Brief:
Oral Testosterone for the Treatment of Hypogonadism in Males
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Period 2: Two Times Daily Dosing 90 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. | None | None | 0 | 21 | 7 | 21 | View |
| Period 1: Single Dose | Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2. | None | None | 0 | 25 | 5 | 25 | View |
| Period 3: Two Times Daily Dosing 120 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. | None | None | 0 | 4 | 1 | 4 | View |
| Period 3: Three Times Daily Dosing 90 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. | None | None | 0 | 1 | 1 | 1 | View |
| Period 3: Two Times Daily Dosing 180 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. | None | None | 1 | 8 | 2 | 8 | View |
| Period 3: Three Times Daily Dosing 120 mg | Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated. Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment. | None | None | 0 | 8 | 2 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.1) | View |
| Testicular pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (17.1) | View |
| Prostatic specific antigen increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Blood potassium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |