NCT00515203 · OUTCOME

Increase in Platelet Count ≥ 20 x 10^9/L Above Baseline for Two Consecutive Weeks

Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects · Source last updated 2014-07-25

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: 12-week treatment period

What was measured

Participant incidence of achieving an increase in platelet count ≥20 x 10\^9/L above baseline for two consecutive weeks during the 12 week treatment period.

Analysis population: Efficacy Analysis Set, composed of all randomized participants

Groups in this outcome

Romiplostim

Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg

Placebo

Placebo by subcutaneous injection once weekly

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
Romiplostim	17
Placebo	5

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Romiplostim	15	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0008
statistical Method
Fisher Exact
tested Non Inferiority
false

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0008
statistical Method
Fisher Exact
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
value
15
group Id
OG001
value
0

denoms

counts
group Id
OG000
value
17
group Id
OG001
value
5
units
Participants

description

Participant incidence of achieving an increase in platelet count ≥20 x 10\^9/L above baseline for two consecutive weeks during the 12 week treatment period.

groups

description
Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
id
OG000
title
Romiplostim
description
Placebo by subcutaneous injection once weekly
id
OG001
title
Placebo

param Type

NUMBER

population Description

Efficacy Analysis Set, composed of all randomized participants

reporting Status

POSTED

time Frame

12-week treatment period

title

Increase in Platelet Count ≥ 20 x 10^9/L Above Baseline for Two Consecutive Weeks

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice