NCT00445484 · ADVERSE EVENTS

Adverse events

Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2015-08-24

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: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group 1 Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine). pneumococcal polyvalent vaccine: Given intramuscularly lenalidomide: Given orally	1 / 11	1 / 11	Not reported / Not reported
Group 2 Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine). pneumococcal polyvalent vaccine: Given intramuscularly lenalidomide: Given orally	0 / 11	1 / 11	Not reported / Not reported

Group identifiers: EG000: Group 1 · EG001: Group 2

Serious adverse events

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

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Thrombocytopenia

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
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Lower back pain
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Anemia
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Shortness of breath on exertion
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Renal insufficiency
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Hypertension
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Hyperlipidemia
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Cough
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Rash

Complete source fields

event Groups

description
Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine). pneumococcal polyvalent vaccine: Given intramuscularly lenalidomide: Given orally
id
EG000
other Num Affected
1
other Num At Risk
11
serious Num Affected
1
serious Num At Risk
11
title
Group 1
description
Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine). pneumococcal polyvalent vaccine: Given intramuscularly lenalidomide: Given orally
id
EG001
other Num Affected
1
other Num At Risk
11
serious Num Affected
0
serious Num At Risk
11
title
Group 2

frequency Threshold

other Events

organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Lower back pain
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Anemia
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Shortness of breath on exertion
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Renal insufficiency
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Hypertension
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Hyperlipidemia
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Cough
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
11
num Events
1
term
Rash

serious Events

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
11
num Events
0
term
Thrombocytopenia

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Preserved source evidence · Not medical advice