NCT03634800 · ADVERSE EVENTS

Adverse events

Radiotherapy With Immunotherapy for Systemic Effect in Myeloma (RISE-M) · Source last updated 2021-08-05

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 event data is collected from the date of consent until patients withdraw consent. Patients removed from the the study treatment due to disease progression or unacceptable toxicity will be followed until their adverse event returns to baseline values or until study completion, whichever occurs first, unless they withdraw consent.
Other-event reporting threshold: 0%

1 subject withdrew consent before to starting treatment and no AEs were collected, so only 5 subjects were evaluated for AEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Nivolumab/Radiotherapy All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy (6 Gy x 5 fractions) to a targetable lesion. * Nivolumab 240 mg IV starts with the first radiotherapy fraction 240 mg IV every 2 weeks from first radiotherapy fraction until disease prograssion or dose limiting toxicity is reached * Radiotherapy Dose of 6 Gy x 5 days will be given (patients will receive 1 fraction over 5 days for a total of 5 fractions) during the first week of starting Nivolumab Nivolumab 240mg: Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached. Radiation therapy: Patients will receive radiation for 5 consecutive days. A dose of 6 Gy x 5 days will be administered. Patients may receive radiotherapy to an additional site at 12 weeks if they have stable disease.	2 / 5	5 / 5	2 / 5

Group identifiers: EG000: Nivolumab/Radiotherapy

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
Grade 4 platelet count decreased
organ System
Investigations
source Vocabulary
Low platelet count
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3 Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3 back pain
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Back pain

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
notes
Grade 3 Nausea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Peripheral motor neuropathy
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
term
Peripheral motor neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Arthralgia
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Back pain
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Fatigue
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Myalgia
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Bloating
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 and Grade 2 Bone Pain
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
2
term
bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3 Vomiting
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Creatinine increased
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3 Alkaline phosphatase increased
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Alkaline phosphatase increased

Complete source fields

description

1 subject withdrew consent before to starting treatment and no AEs were collected, so only 5 subjects were evaluated for AEs.

event Groups

deaths Num Affected
2
deaths Num At Risk
5
description
All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy (6 Gy x 5 fractions) to a targetable lesion. * Nivolumab 240 mg IV starts with the first radiotherapy fraction 240 mg IV every 2 weeks from first radiotherapy fraction until disease prograssion or dose limiting toxicity is reached * Radiotherapy Dose of 6 Gy x 5 days will be given (patients will receive 1 fraction over 5 days for a total of 5 fractions) during the first week of starting Nivolumab Nivolumab 240mg: Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached. Radiation therapy: Patients will receive radiation for 5 consecutive days. A dose of 6 Gy x 5 days will be administered. Patients may receive radiotherapy to an additional site at 12 weeks if they have stable disease.
id
EG000
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Nivolumab/Radiotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3 Nausea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Peripheral motor neuropathy
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
term
Peripheral motor neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Arthralgia
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Back pain
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Fatigue
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Myalgia
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Bloating
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 and Grade 2 Bone Pain
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
2
term
bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3 Vomiting
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1 Creatinine increased
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3 Alkaline phosphatase increased
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Alkaline phosphatase increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 4 platelet count decreased
organ System
Investigations
source Vocabulary
Low platelet count
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3 Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3 back pain
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
term
Back pain

time Frame

Adverse event data is collected from the date of consent until patients withdraw consent. Patients removed from the the study treatment due to disease progression or unacceptable toxicity will be followed until their adverse event returns to baseline values or until study completion, whichever occurs first, unless they withdraw consent.

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Preserved source evidence · Not medical advice