NCT03267888 · ADVERSE EVENTS

Adverse events

Pembrolizumab and Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-09-04

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: The first 12 months of treatment
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Radiation Therapy, Pembrolizumab Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab IV over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given 200 mg/kg IV. Radiation Therapy: Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.	1 / 25	8 / 25	10 / 25

Group identifiers: EG000: Radiation Therapy, Pembrolizumab

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Fatigue

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
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
25
num Events
4
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Rigours during infusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Hypothyroidism

Complete source fields

event Groups

deaths Num Affected
10
deaths Num At Risk
25
description
Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab IV over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given 200 mg/kg IV. Radiation Therapy: Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.
id
EG000
other Num Affected
8
other Num At Risk
25
serious Num Affected
1
serious Num At Risk
25
title
Radiation Therapy, Pembrolizumab

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
25
num Events
4
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Rigours during infusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Hypothyroidism

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Fatigue

time Frame

The first 12 months of treatment

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

Preserved source evidence · Not medical advice