NCT02919670 · OUTCOME

Calorie Consumption

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: MEDIAN
Unit: calories
Interval / dispersion: Full Range
Time frame: 14 days

Analysis population: 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

Admission

Values in calories · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Enterade and Standard Supportive Care	1848.5	Not reported	352	2919	Not reported
Placebo and Standard Supportive Care	1790	Not reported	680	2793	Not reported

D+7

Values in calories · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Enterade and Standard Supportive Care	625.5	Not reported	0	2523	Not reported
Placebo and Standard Supportive Care	720	Not reported	0	2770	Not reported

D+14

Values in calories · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Enterade and Standard Supportive Care	800	Not reported	0	2300	Not reported
Placebo and Standard Supportive Care	922	Not reported	0	3174	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
352
upper Limit
2919
value
1848.5
group Id
OG001
lower Limit
680
upper Limit
2793
value
1790
title
Admission
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
2523
value
625.5
group Id
OG001
lower Limit
0
upper Limit
2770
value
720
title
D+7
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
2300
value
800
group Id
OG001
lower Limit
0
upper Limit
3174
value
922
title
D+14

denoms

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

dispersion Type

Full Range

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

MEDIAN

population Description

Only 17 participants met the protocol definition of compliance

reporting Status

POSTED

time Frame

14 days

title

Calorie Consumption

type

SECONDARY

unit Of Measure

calories

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

Preserved source evidence · Not medical advice