TriangleNCT01356602 · OUTCOME
Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Hours
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 14 days
What was measured
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.
Analysis population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Groups in this outcome
Canakinumab, Pre-filled Syringes (PFS)
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
Canakinumab, Lyophilizate (LYO)
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
Triamcinolone Acetonide
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
| Group | Source count |
|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 130 |
| Canakinumab, Lyophilizate (LYO) | 129 |
| Triamcinolone Acetonide | 129 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 24 | Not reported | 22 | 25 | Not reported |
| Canakinumab, Lyophilizate (LYO) | 25 | Not reported | 24 | 48 | Not reported |
| Triamcinolone Acetonide | 48 | Not reported | 25 | 54 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22
- upper Limit
- 25
- value
- 24
- group Id
- OG001
- lower Limit
- 24
- upper Limit
- 48
- value
- 25
- group Id
- OG002
- lower Limit
- 25
- upper Limit
- 54
- value
- 48
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 129
- group Id
- OG002
- value
- 129
- units
- Participants
- description
- The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
- id
- OG000
- title
- Canakinumab, Pre-filled Syringes (PFS)
- description
- The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
- id
- OG001
- title
- Canakinumab, Lyophilizate (LYO)
- description
- The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
- id
- OG002
- title
- Triamcinolone Acetonide
- param Type
- MEDIAN
- population Description
- Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
- reporting Status
- POSTED
- time Frame
- 14 days
- title
- Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS
- type
- SECONDARY
- unit Of Measure
- Hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice