NCT00567229 · ADVERSE EVENTS

Adverse events

Lenalidomide and Rituximab in Treating Patients With Recurrent and/or Refractory Multiple Myeloma · Source last updated 2015-11-20

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
Lenalidomide and Rituximab This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.	1 / 3	3 / 3	Not reported / Not reported

Group identifiers: EG000: Lenalidomide and Rituximab

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
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Pulmonary/upper respiratory

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
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
PT INR
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Neuropathy: sensory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
term
Neutrophils/granulocytes

Complete source fields

event Groups

description
This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Lenalidomide and Rituximab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
PT INR
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Neuropathy: sensory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
term
Neutrophils/granulocytes

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Pulmonary/upper respiratory

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Preserved source evidence · Not medical advice