NCT00309907 · OUTCOME

Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.

Etanercept in Treating Young Patients With Idiopathic Pneumonia Syndrome After Undergoing a Donor Stem Cell Transplant · Source last updated 2017-09-29

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: At day 28

What was measured

Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for \> 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response.

Analysis population: Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.

Groups in this outcome

Etanercept and Corticosteroid Therapy

Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56. etanercept: Given IV and subcutaneously methylprednisolone: Given IV and orally

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
Etanercept and Corticosteroid Therapy	28

Reported measurements

With Response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Etanercept and Corticosteroid Therapy	20	Not reported	Not reported	Not reported	Not reported

Without Response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Etanercept and Corticosteroid Therapy	8	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
20
title
With Response
categories
measurements
group Id
OG000
value
8
title
Without Response

denoms

counts
group Id
OG000
value
28
units
Participants

description

groups

description
Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56. etanercept: Given IV and subcutaneously methylprednisolone: Given IV and orally
id
OG000
title
Etanercept and Corticosteroid Therapy

param Type

NUMBER

population Description

Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.

reporting Status

POSTED

time Frame

At day 28

title

Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.

type

PRIMARY

unit Of Measure

participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice