NCT04467697 · OUTCOME
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men · Source last updated 2024-06-28
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 180 days
What was measured
Number of subjects of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study withdrawal in SOV2012-F1-treated subjects
Analysis population: Extension Treated Set
Groups in this outcome
SOV2012-F1-treated
Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| SOV2012-F1-treated | 155 |
|---|
Reported measurements
Any TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated | 58 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Serious TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Treatment-related TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Treatment-related Serious TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Severe TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Treatment-related Severe TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAEs leading to Discontinuation from Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAEs leading to Death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Any MACE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Any TEAEs of Hypertension or Blood Pressure Increased
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Any TEAEs
- title
- Any Serious TEAEs
- title
- Any Treatment-related TEAEs
- title
- Any Treatment-related Serious TEAEs
- title
- Any Severe TEAEs
- title
- Any Treatment-related Severe TEAEs
- title
- Any TEAEs leading to Discontinuation from Study Drug
- title
- Any TEAEs leading to Death
- title
- Any MACE
- title
- Any TEAEs of Hypertension or Blood Pressure Increased
- description
- Number of subjects of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study withdrawal in SOV2012-F1-treated subjects
- groups
- description
- Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
- id
- OG000
- title
- SOV2012-F1-treated
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Extension Treated Set
- reporting Status
- POSTED
- time Frame
- 180 days
- title
- AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
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