TriangleNCT01356602 · OUTCOME
Patient's Assessment of Pain Intensity on a 5-point Likert Scale
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Patients
- Interval / dispersion
- Not reported
- Time frame
- 72 hours
What was measured
A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.
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) | 131 |
| Canakinumab, Lyophilizate (LYO) | 129 |
| Triamcinolone Acetonide | 128 |
Reported measurements
None
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 35.9 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 32.6 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 23.4 | Not reported | Not reported | Not reported | Not reported |
Mild
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 45.8 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 44.2 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 36.7 | Not reported | Not reported | Not reported | Not reported |
Moderate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 15.3 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 21.7 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 21.9 | Not reported | Not reported | Not reported | Not reported |
Severe
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 2.3 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 1.6 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 14.1 | Not reported | Not reported | Not reported | Not reported |
Extreme
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 0.8 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 0 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 3.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 35.9
- group Id
- OG001
- value
- 32.6
- group Id
- OG002
- value
- 23.4
- title
- None
- categories
- measurements
- group Id
- OG000
- value
- 45.8
- group Id
- OG001
- value
- 44.2
- group Id
- OG002
- value
- 36.7
- title
- Mild
- categories
- measurements
- group Id
- OG000
- value
- 15.3
- group Id
- OG001
- value
- 21.7
- group Id
- OG002
- value
- 21.9
- title
- Moderate
- categories
- measurements
- group Id
- OG000
- value
- 2.3
- group Id
- OG001
- value
- 1.6
- group Id
- OG002
- value
- 14.1
- title
- Severe
- categories
- measurements
- group Id
- OG000
- value
- 0.8
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3.9
- title
- Extreme
- denoms
- counts
- group Id
- OG000
- value
- 131
- group Id
- OG001
- value
- 129
- group Id
- OG002
- value
- 128
- units
- Participants
- description
- A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.
- 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
- NUMBER
- 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
- 72 hours
- title
- Patient's Assessment of Pain Intensity on a 5-point Likert Scale
- type
- SECONDARY
- unit Of Measure
- Percentage of Patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice