NCT01621672 · ADVERSE EVENTS

Adverse events

UARK 2009-09 Myeloma Cure Project: Prospective Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma · Source last updated 2015-10-19

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Revlimid Revlimid: 10 mg/day in the morning same time each day	18 / 25	25 / 25	Not reported / Not reported
Observation No treatment	17 / 17	17 / 17	Not reported / Not reported

Group identifiers: EG000: Revlimid · EG001: Observation

Serious adverse events

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

organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Allergic reaction/Hypersensitivity
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 4 Neutropenia/granulocytopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
17
term
Grade 4 Thrombocyopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
17
term
Grade 4 Leukopenia
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Skin Rash/desquamation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Dysphagia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
17
term
Grade 4 Hypocalcemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Hypokalemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
4
num At Risk
17
term
Grade 3 Hypophosphatemia
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Gait/ walking
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 CNS Ischemia
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Mood alteration

Other reported adverse events

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

organ System
Immune system disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 1 Rhinitis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
17
term
Grade 1 Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
13
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 1 Thrombocytopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
9
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 2 Leukopenia
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
17
term
Grade 1 Fatigue
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 2 Hypothyroidism
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 1 Constipation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 1 Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 2 Diarrhea
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
17
term
Grade 1 Alkaline phosphatase increase
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
4
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
17
term
Grade 1 Bilirubin increase

Complete source fields

event Groups

description
Revlimid: 10 mg/day in the morning same time each day
id
EG000
other Num Affected
25
other Num At Risk
25
serious Num Affected
18
serious Num At Risk
25
title
Revlimid
description
No treatment
id
EG001
other Num Affected
17
other Num At Risk
17
serious Num Affected
17
serious Num At Risk
17
title
Observation

frequency Threshold

other Events

organ System
Immune system disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 1 Rhinitis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
17
term
Grade 1 Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
13
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 1 Thrombocytopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
9
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 2 Leukopenia
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
17
term
Grade 1 Fatigue
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 2 Hypothyroidism
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 1 Constipation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 1 Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 2 Diarrhea
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
17
term
Grade 1 Alkaline phosphatase increase
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
4
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
17
term
Grade 1 Bilirubin increase

serious Events

organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Allergic reaction/Hypersensitivity
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 4 Neutropenia/granulocytopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
17
term
Grade 4 Thrombocyopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
17
term
Grade 4 Leukopenia
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Skin Rash/desquamation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Dysphagia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
17
term
Grade 4 Hypocalcemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Hypokalemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
4
num At Risk
17
term
Grade 3 Hypophosphatemia
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Gait/ walking
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 CNS Ischemia
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
0
num At Risk
17
term
Grade 3 Mood alteration

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