NCT05565638 · ADVERSE EVENTS

Adverse events

PROFAST Intervention in Precursor Multiple Myeloma · Source last updated 2026-10-07

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: 4 months
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
PROLONGED FASTING INTERVENTION The prolonged nightly fasting (PROFAST) intervention involves gradually working up to a 14-hour fast during the nighttime hours. Participants will be supported by means of calls with a health coach during the first 4 weeks of the study. Participants will also be asked to use a text messaging platform to record their first and last meal of the day, and will receive personalized feedback based on the meal times they record via the text messaging system. The text messaging system will be used throughout the duration of the study. Prolonged Fasting Intervention: promote a 14-hour fast during the nighttime hours	0 / 11	0 / 11	0 / 11
EDUCATION CONTROL For participants randomized to the control group, an introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living during the 4 months of the study EDUCATION CONTROL: introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living	0 / 12	0 / 12	0 / 12

Group identifiers: EG000: PROLONGED FASTING INTERVENTION · EG001: EDUCATION CONTROL

Serious adverse events

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

Other reported adverse events

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

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
11
description
The prolonged nightly fasting (PROFAST) intervention involves gradually working up to a 14-hour fast during the nighttime hours. Participants will be supported by means of calls with a health coach during the first 4 weeks of the study. Participants will also be asked to use a text messaging platform to record their first and last meal of the day, and will receive personalized feedback based on the meal times they record via the text messaging system. The text messaging system will be used throughout the duration of the study. Prolonged Fasting Intervention: promote a 14-hour fast during the nighttime hours
id
EG000
other Num Affected
0
other Num At Risk
11
serious Num Affected
0
serious Num At Risk
11
title
PROLONGED FASTING INTERVENTION
deaths Num Affected
0
deaths Num At Risk
12
description
For participants randomized to the control group, an introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living during the 4 months of the study EDUCATION CONTROL: introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living
id
EG001
other Num Affected
0
other Num At Risk
12
serious Num Affected
0
serious Num At Risk
12
title
EDUCATION CONTROL

frequency Threshold

time Frame

4 months

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Preserved source evidence · Not medical advice