NCT02919670 · OUTCOME

the Tolerability of Enterade® as Measured by the Number of Compliant Patients

A Study Evaluating a Proprietary Amino Acid Mixture (Enterade®) in Patients Receiving High-Dose Melphalan Conditioning Followed by Autologous Stem Cell Transplantation for Multiple Myeloma and Non-Hodgkin Lymphoma · Source last updated 2023-03-16

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 14 days

Analysis population: Patients who take the study drug two 8 oz. bottles (480 ml) daily for at least 11 days are regarded as compliant. Compliance is assessed among patients who received any amount of the study drug (N=99).Only 17 participants met the protocol definition of compliance

Groups in this outcome

Enterade and Standard Supportive Care

* Two 8 oz. bottles of Enterade will be administered daily * Enterade will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Enterade Standard Supportive Care

Placebo and Standard Supportive Care

* Two 8 oz. bottles of Placebo will be administered daily * Placebo will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Placebo Standard Supportive Care

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
Enterade and Standard Supportive Care	49
Placebo and Standard Supportive Care	50

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enterade and Standard Supportive Care	6	Not reported	Not reported	Not reported	Not reported
Placebo and Standard Supportive Care	11	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
6
group Id
OG001
value
11

denoms

counts
group Id
OG000
value
49
group Id
OG001
value
50
units
Participants

groups

description
* Two 8 oz. bottles of Enterade will be administered daily * Enterade will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Enterade Standard Supportive Care
id
OG000
title
Enterade and Standard Supportive Care
description
* Two 8 oz. bottles of Placebo will be administered daily * Placebo will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Placebo Standard Supportive Care
id
OG001
title
Placebo and Standard Supportive Care

param Type

COUNT_OF_PARTICIPANTS

population Description

Patients who take the study drug two 8 oz. bottles (480 ml) daily for at least 11 days are regarded as compliant. Compliance is assessed among patients who received any amount of the study drug (N=99).Only 17 participants met the protocol definition of compliance

reporting Status

POSTED

time Frame

14 days

title

the Tolerability of Enterade® as Measured by the Number of Compliant Patients

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice