NCT01729338 · ADVERSE EVENTS

Adverse events

Velcade + Cyclophosphamide in Newly Diagnosed Multiple Myeloma · Source last updated 2017-05-31

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: 1st day of drug till 30 days after last dose
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Velcade, Cyclophosphamide, Revlimid INDUCTION (28-day cycles for 8 cycles): * VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15 * Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15 * Dexamethasone 40 mg PO days 1,8 and 15 MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death): * Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21 * Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15 Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until	9 / 14	14 / 14	Not reported / Not reported

Group identifiers: EG000: Velcade, Cyclophosphamide, Revlimid

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
Gastrointestinal disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Infections and infestations - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Muscle weakness upper limb
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Paresthesia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Delirium
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Respiratory failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Hematoma

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
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
7
num At Risk
14
num Events
19
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
2
term
Cardiac disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Ear and labyrinth disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Hearing impaired
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
4
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
3
term
Blurred vision
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Eye disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Eye pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
5
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
4
num At Risk
14
num Events
12
term
Constipation

Complete source fields

event Groups

description
INDUCTION (28-day cycles for 8 cycles): * VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15 * Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15 * Dexamethasone 40 mg PO days 1,8 and 15 MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death): * Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21 * Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15 Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
id
EG000
other Num Affected
14
other Num At Risk
14
serious Num Affected
9
serious Num At Risk
14
title
Velcade, Cyclophosphamide, Revlimid

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
7
num At Risk
14
num Events
19
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
2
term
Cardiac disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Chest pain - cardiac
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Ear and labyrinth disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Hearing impaired
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
4
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
3
term
Blurred vision
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Eye disorders - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Eye pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
5
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
4
num At Risk
14
num Events
12
term
Constipation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Infections and infestations - Other, specify
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Muscle weakness upper limb
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Paresthesia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Delirium
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Respiratory failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
NCI CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
14
term
Hematoma

time Frame

1st day of drug till 30 days after last dose

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Preserved source evidence · Not medical advice