TriangleNCT00410514 · OUTCOME
Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
What was measured
Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.
Analysis population: The Safety Analysis set included all participants who received at least one dose of study drug.
Groups in this outcome
Placebo
Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
Mirabegron 50 mg
Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
Mirabegron 100 mg
Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
| Group | Source count |
|---|---|
| Placebo | 65 |
| Mirabegron 50 mg | 70 |
| Mirabegron 100 mg | 65 |
Reported measurements
Adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 28 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | 28 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | 34 | Not reported | Not reported | Not reported | Not reported |
Mild intensity adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 17 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | 16 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | 20 | Not reported | Not reported | Not reported | Not reported |
Moderate intensity adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 7 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | 10 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | 14 | Not reported | Not reported | Not reported | Not reported |
Severe intensity adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 4 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Drug-related adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 8 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | 11 | Not reported | Not reported | Not reported | Not reported |
Serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | 0 | Not reported | Not reported | Not reported | Not reported |
AEs leading to study drug discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | 2 | Not reported | Not reported | Not reported | Not reported |
Deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 50 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Mirabegron 100 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 34
- title
- Adverse events
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 20
- title
- Mild intensity adverse events
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 14
- title
- Moderate intensity adverse events
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- title
- Severe intensity adverse events
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 11
- title
- Drug-related adverse events
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Serious adverse events
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- title
- AEs leading to study drug discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Deaths
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 70
- group Id
- OG002
- value
- 65
- units
- Participants
- description
- Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.
- groups
- description
- Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
- id
- OG000
- title
- Placebo
- description
- Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
- id
- OG001
- title
- Mirabegron 50 mg
- description
- Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
- id
- OG002
- title
- Mirabegron 100 mg
- param Type
- NUMBER
- population Description
- The Safety Analysis set included all participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
- title
- Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice