NCT02919670 · OUTCOME

Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity

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

What was measured

Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention

Analysis population: Only 17 participants met the protocol definition of compliance

Groups in this outcome

Enterade

Participants who received Enterade

Placebo

Participants who received placebo

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	49
Placebo	50

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enterade	18	Not reported	Not reported	Not reported	Not reported
Placebo	21	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
18
group Id
OG001
value
21

denoms

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

description

Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention

groups

description
Participants who received Enterade
id
OG000
title
Enterade
description
Participants who received placebo
id
OG001
title
Placebo

param Type

COUNT_OF_PARTICIPANTS

population Description

Only 17 participants met the protocol definition of compliance

reporting Status

POSTED

time Frame

14 days

title

Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice