NCT02994784 · ADVERSE EVENTS

Adverse events

Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients · Source last updated 2023-05-24

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 12 months
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Evomela Propylene Glycol-Free Melphalan Hydrochloride (Evomela) administered intravenously at 70-100 mg/m2/day on Days -3 and -2 prior to autologous stem cell transplantation Propylene Glycol-Free Melphalan Hydrochloride: Intravenous Propylene Glycol-Free Melphalan Hydrochloride	20 / 27	25 / 27	0 / 27

Group identifiers: EG000: Evomela

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
New cardiac arrhythmias
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
4
num At Risk
27
num Events
4
term
Cardiac arrhythmias
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
2
num At Risk
27
num Events
2
term
Renal dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
14
num At Risk
27
num Events
14
term
Autonomic dysfunction

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
25
num At Risk
27
num Events
25
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
20
num At Risk
27
num Events
20
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
22
num At Risk
27
num Events
22
term
Fatigue

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
27
description
Propylene Glycol-Free Melphalan Hydrochloride (Evomela) administered intravenously at 70-100 mg/m2/day on Days -3 and -2 prior to autologous stem cell transplantation Propylene Glycol-Free Melphalan Hydrochloride: Intravenous Propylene Glycol-Free Melphalan Hydrochloride
id
EG000
other Num Affected
25
other Num At Risk
27
serious Num Affected
20
serious Num At Risk
27
title
Evomela

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
25
num At Risk
27
num Events
25
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
20
num At Risk
27
num Events
20
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
22
num At Risk
27
num Events
22
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
New cardiac arrhythmias
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
4
num At Risk
27
num Events
4
term
Cardiac arrhythmias
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
2
num At Risk
27
num Events
2
term
Renal dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
14
num At Risk
27
num Events
14
term
Autonomic dysfunction

time Frame

12 months

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

Preserved source evidence · Not medical advice