NCT00691704 · ADVERSE EVENTS

Adverse events

Celgene High Risk Multiple Myeloma (MM) Revlimid Induction and Maintenance Therapy · Source last updated 2014-08-19

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: Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness.
Other-event reporting threshold: 0%

Toxicities and adverse events were scored using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The investigator evaluated each adverse experience for its relationship to the test drug and for its seriousness.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
High-risk Multiple Myeloma Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on	4 / 18	18 / 18	Not reported / Not reported

Group identifiers: EG000: High-risk Multiple Myeloma

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
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Supraventricular and nodal arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Chest Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Congestive Heart Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Ventricular Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Cardiac Ischemia / infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Acute Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Bacteremia
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Infection with normal ANC or Grade 1 or 2 neutrophils
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Glucose, serum-high (hyperglycemia)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Muscular / skeletal hypoplasia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
fainting
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Syncope

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
Ear and labyrinth disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Otitis, external ear (non-infectious)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
thrombosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Bacteremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
5
num At Risk
18
num Events
5
term
Hemoglobin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
10
num At Risk
18
num Events
10
term
anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
15
num At Risk
18
num Events
15
term
Leukocytes (total WBC)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
10
num At Risk
18
num Events
10
term
leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
13
num At Risk
18
num Events
13
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
4
num At Risk
18
num Events
4
term
Lymphocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
18
num At Risk
18
num Events
20
term
Neutrophils / granulocytes (ANC / AGC)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
12
num At Risk
18
num Events
12
term
Platelets
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
9
num At Risk
18
num Events
9
term
thrombocytopenia

Complete source fields

description

event Groups

description
Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles. Sequential Maintenance Therapy: Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician): * 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis * Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle * Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7 * Prednisone 60 mg /m2 po daily on
id
EG000
other Num Affected
18
other Num At Risk
18
serious Num Affected
4
serious Num At Risk
18
title
High-risk Multiple Myeloma

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Otitis, external ear (non-infectious)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
thrombosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Bacteremia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
5
num At Risk
18
num Events
5
term
Hemoglobin
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
10
num At Risk
18
num Events
10
term
anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
15
num At Risk
18
num Events
15
term
Leukocytes (total WBC)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
10
num At Risk
18
num Events
10
term
leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
13
num At Risk
18
num Events
13
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
4
num At Risk
18
num Events
4
term
Lymphocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
18
num At Risk
18
num Events
20
term
Neutrophils / granulocytes (ANC / AGC)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
12
num At Risk
18
num Events
12
term
Platelets
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
9
num At Risk
18
num Events
9
term
thrombocytopenia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Supraventricular and nodal arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Chest Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Congestive Heart Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Ventricular Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Cardiac Ischemia / infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Acute Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Bacteremia
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Infection with normal ANC or Grade 1 or 2 neutrophils
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Glucose, serum-high (hyperglycemia)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Muscular / skeletal hypoplasia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
fainting
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
18
num Events
1
term
Syncope

time Frame

Monitoring of adverse events was conducted through the study period and 30 days following the last dose of lenalidomide. All subjects with adverse events were monitored until resolved or determined to be due to a subject's intercurrent illness.

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