NCT00886769 · OUTCOME

Percentage of Patients Who Had Body Temperature ≤ 38°C

Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) · Source last updated 2017-03-29

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

Measure: NUMBER
Unit: Percent of participants
Interval / dispersion: Not reported
Time frame: Day 3

What was measured

Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.

Analysis population: The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.

Groups in this outcome

Canakinumab

Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections.

Placebo

Patients received a single dose matching placebo of canakinumab on day 1.

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

Analysis denominator · Participants

Group	Source count
Canakinumab	43
Placebo	38

Reported measurements

Source class 1

Values in Percent of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Canakinumab	100	Not reported	Not reported	Not reported	Not reported
Placebo	86.8	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
100
group Id
OG001
value
86.8

denoms

counts
group Id
OG000
value
43
group Id
OG001
value
38
units
Participants

description

Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.

groups

description
Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections.
id
OG000
title
Canakinumab
description
Patients received a single dose matching placebo of canakinumab on day 1.
id
OG001
title
Placebo

param Type

NUMBER

population Description

The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.

reporting Status

POSTED

time Frame

Day 3

title

Percentage of Patients Who Had Body Temperature ≤ 38°C

type

SECONDARY

unit Of Measure

Percent of participants

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

Preserved source evidence · Not medical advice