NCT03262389 · ADVERSE EVENTS

Adverse events

Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma · Source last updated 2021-03-16

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: Adverse Events were collected from baseline to one day following the last administration of study treatment, for at total of approximately 3 days.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Multiple Myeloma (MM) Patients New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups. Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi). Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).	0 / 10	0 / 10	0 / 10

Group identifiers: EG000: Multiple Myeloma (MM) Patients

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
10
description
New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups. Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi). Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).
id
EG000
other Num Affected
0
other Num At Risk
10
serious Num Affected
0
serious Num At Risk
10
title
Multiple Myeloma (MM) Patients

frequency Threshold

time Frame

Adverse Events were collected from baseline to one day following the last administration of study treatment, for at total of approximately 3 days.

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

Preserved source evidence · Not medical advice