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NCT01356602 · OUTCOME

Amount of Rescue Medication Taken (mg)

Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients · Source last updated 2014-01-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
milligrams (mg)
Interval / dispersion
Standard Deviation
Time frame
14 days

What was measured

Patients used a diary to record the time of intake of rescue medication and the amount taken.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Canakinumab, Pre-filled Syringes (PFS)131
Canakinumab, Lyophilizate (LYO)129
Triamcinolone Acetonide129

Reported measurements

Acetaminophen
Values in milligrams (mg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)609.21800.06Not reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)1108.32821.54Not reportedNot reportedNot reported
Triamcinolone Acetonide2323.15580.82Not reportedNot reportedNot reported
Codeine
Values in milligrams (mg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)12.755.30Not reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)23.9124.56Not reportedNot reportedNot reported
Triamcinolone Acetonide60.8191.2Not reportedNot reportedNot reported
Prednisolone / Prednisone
Values in milligrams (mg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Canakinumab, Pre-filled Syringes (PFS)5.823.13Not reportedNot reportedNot reported
Canakinumab, Lyophilizate (LYO)6.725.09Not reportedNot reportedNot reported
Triamcinolone Acetonide24.753.20Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1800.06
        value
        609.2
      2. group Id
        OG001
        spread
        2821.54
        value
        1108.3
      3. group Id
        OG002
        spread
        5580.82
        value
        2323.1
    title
    Acetaminophen
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.30
        value
        12.7
      2. group Id
        OG001
        spread
        124.56
        value
        23.9
      3. group Id
        OG002
        spread
        191.2
        value
        60.8
    title
    Codeine
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.13
        value
        5.8
      2. group Id
        OG001
        spread
        25.09
        value
        6.7
      3. group Id
        OG002
        spread
        53.20
        value
        24.7
    title
    Prednisolone / Prednisone
denoms
  1. counts
    1. group Id
      OG000
      value
      131
    2. group Id
      OG001
      value
      129
    3. group Id
      OG002
      value
      129
    units
    Participants
description
Patients used a diary to record the time of intake of rescue medication and the amount taken.
dispersion Type
Standard Deviation
groups
  1. 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)
  2. 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)
  3. 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
MEAN
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
Amount of Rescue Medication Taken (mg)
type
SECONDARY
unit Of Measure
milligrams (mg)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice