TriangleNCT01080131 · OUTCOME
Number of Participants With Adverse Events, Death and Serious Adverse Events (72 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
- 72 weeks
What was measured
This was the primary endpoint of extension study 2. An adverse event was 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
All Canakinumab
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants 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. In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare. In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months.
Canakinumab: Before Retreatment
Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
Canakinumab: After Retreatment
Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
All Triamcinolone Acetonide
Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare. Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab.
Triam: Before Switch to Canakinumab
Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
Triam: After Switch to Canakinumab
Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
| Group | Source count |
|---|---|
| All Canakinumab | 112 |
| Canakinumab: Before Retreatment | 62 |
| Canakinumab: After Retreatment | 62 |
| All Triamcinolone Acetonide | 114 |
| Triam: Before Switch to Canakinumab | 41 |
| Triam: After Switch to Canakinumab | 41 |
Reported measurements
Any adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Canakinumab | 85 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab: Before Retreatment | 44 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab: After Retreatment | 39 | Not reported | Not reported | Not reported | Not reported |
| All Triamcinolone Acetonide | 70 | Not reported | Not reported | Not reported | Not reported |
| Triam: Before Switch to Canakinumab | 29 | Not reported | Not reported | Not reported | Not reported |
| Triam: After Switch to Canakinumab | 27 | Not reported | Not reported | Not reported | Not reported |
Death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Canakinumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab: Before Retreatment | 0 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab: After Retreatment | 0 | Not reported | Not reported | Not reported | Not reported |
| All Triamcinolone Acetonide | 0 | Not reported | Not reported | Not reported | Not reported |
| Triam: Before Switch to Canakinumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Triam: After Switch to Canakinumab | 0 | Not reported | Not reported | Not reported | Not reported |
Serious adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Canakinumab | 12 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab: Before Retreatment | 1 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab: After Retreatment | 5 | Not reported | Not reported | Not reported | Not reported |
| All Triamcinolone Acetonide | 4 | Not reported | Not reported | Not reported | Not reported |
| Triam: Before Switch to Canakinumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Triam: After Switch to Canakinumab | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 85
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 39
- group Id
- OG003
- value
- 70
- group Id
- OG004
- value
- 29
- group Id
- OG005
- value
- 27
- title
- Any adverse event
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Death
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 3
- title
- Serious adverse event
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 62
- group Id
- OG002
- value
- 62
- group Id
- OG003
- value
- 114
- group Id
- OG004
- value
- 41
- group Id
- OG005
- value
- 41
- units
- Participants
- description
- This was the primary endpoint of extension study 2. An adverse event was 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
- Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants 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. In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare. In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months.
- id
- OG000
- title
- All Canakinumab
- description
- Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
- id
- OG001
- title
- Canakinumab: Before Retreatment
- description
- Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
- id
- OG002
- title
- Canakinumab: After Retreatment
- description
- Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare. Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab.
- id
- OG003
- title
- All Triamcinolone Acetonide
- description
- Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
- id
- OG004
- title
- Triam: Before Switch to Canakinumab
- description
- Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
- id
- OG005
- title
- Triam: After Switch to Canakinumab
- 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
- 72 weeks
- title
- Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice