TriangleNCT01029652 · OUTCOME
Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)
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
- 24 weeks overall
What was measured
This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Analysis population: Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.
Groups in this outcome
Canakinumab 150 mg
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Triamcinolone Acetonide 40 mg
Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
| Group | Source count |
|---|---|
| Canakinumab 150 mg | 113 |
| Triamcinolone Acetonide 40 mg | 115 |
Reported measurements
Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab 150 mg | 71 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide 40 mg | 56 | Not reported | Not reported | Not reported | Not reported |
Death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide 40 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Serious Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab 150 mg | 11 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide 40 mg | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 56
- title
- Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Death
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- title
- Serious Adverse Event
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 115
- units
- Participants
- description
- This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
- groups
- description
- Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
- id
- OG000
- title
- Canakinumab 150 mg
- description
- Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
- id
- OG001
- title
- Triamcinolone Acetonide 40 mg
- param Type
- NUMBER
- population Description
- Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.
- reporting Status
- POSTED
- time Frame
- 24 weeks overall
- title
- Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice