NCT01302392 · ADVERSE EVENTS

Adverse events

A Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2017-05-02

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: From randomization through the final analysis data cutoff with range of follow-up time of 0.4 - 138.3 weeks with median of 10.7 weeks in Best Supportive Care arm, and 0.3 - 138.4 weeks with median of 16.3 weeks in carfilzomib arm
Other-event reporting threshold: 5%

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Best Supportive Care Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid). Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle).	78 / 153	135 / 153	Not reported / Not reported
Carfilzomib Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days \[Days 1, 2, 8, 9, 15, 16\] for individual subjects).	92 / 157	141 / 157	Not reported / Not reported

Group identifiers: EG000: Best Supportive Care · EG001: Carfilzomib

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
8
num At Risk
153
group Id
EG001
num Affected
4
num At Risk
157
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
153
group Id
EG001
num Affected
3
num At Risk
157
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
153
group Id
EG001
num Affected
0
num At Risk
157
term
Hyperviscosity syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
153
group Id
EG001
num Affected
0
num At Risk
157
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
3
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
5
num At Risk
153
group Id
EG001
num Affected
3
num At Risk
157
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Atrioventricular block complete
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
153
group Id
EG001
num Affected
2
num At Risk
157
term
Cardiac arrest

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
72
num At Risk
153
group Id
EG001
num Affected
88
num At Risk
157
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
15
num At Risk
153
group Id
EG001
num Affected
9
num At Risk
157
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
23
num At Risk
153
group Id
EG001
num Affected
22
num At Risk
157
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
43
num At Risk
153
group Id
EG001
num Affected
58
num At Risk
157
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
20
num At Risk
153
group Id
EG001
num Affected
10
num At Risk
157
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
18
num At Risk
153
group Id
EG001
num Affected
23
num At Risk
157
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
4
num At Risk
153
group Id
EG001
num Affected
10
num At Risk
157
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
14
num At Risk
153
group Id
EG001
num Affected
31
num At Risk
157
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
5
num At Risk
153
group Id
EG001
num Affected
15
num At Risk
157
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
20
num At Risk
153
group Id
EG001
num Affected
26
num At Risk
157
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
8
num At Risk
153
group Id
EG001
num Affected
5
num At Risk
157
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
153
group Id
EG001
num Affected
8
num At Risk
157
term
Chills

Complete source fields

description

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

event Groups

description
Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid). Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle).
id
EG000
other Num Affected
135
other Num At Risk
153
serious Num Affected
78
serious Num At Risk
153
title
Best Supportive Care
description
Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days \[Days 1, 2, 8, 9, 15, 16\] for individual subjects).
id
EG001
other Num Affected
141
other Num At Risk
157
serious Num Affected
92
serious Num At Risk
157
title
Carfilzomib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
72
num At Risk
153
group Id
EG001
num Affected
88
num At Risk
157
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
15
num At Risk
153
group Id
EG001
num Affected
9
num At Risk
157
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
23
num At Risk
153
group Id
EG001
num Affected
22
num At Risk
157
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
43
num At Risk
153
group Id
EG001
num Affected
58
num At Risk
157
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
20
num At Risk
153
group Id
EG001
num Affected
10
num At Risk
157
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
18
num At Risk
153
group Id
EG001
num Affected
23
num At Risk
157
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
4
num At Risk
153
group Id
EG001
num Affected
10
num At Risk
157
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
14
num At Risk
153
group Id
EG001
num Affected
31
num At Risk
157
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
5
num At Risk
153
group Id
EG001
num Affected
15
num At Risk
157
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
20
num At Risk
153
group Id
EG001
num Affected
26
num At Risk
157
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
8
num At Risk
153
group Id
EG001
num Affected
5
num At Risk
157
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
153
group Id
EG001
num Affected
8
num At Risk
157
term
Chills

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
8
num At Risk
153
group Id
EG001
num Affected
4
num At Risk
157
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
153
group Id
EG001
num Affected
3
num At Risk
157
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
153
group Id
EG001
num Affected
0
num At Risk
157
term
Hyperviscosity syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
153
group Id
EG001
num Affected
0
num At Risk
157
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
3
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
5
num At Risk
153
group Id
EG001
num Affected
3
num At Risk
157
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
0
num At Risk
153
group Id
EG001
num Affected
1
num At Risk
157
term
Atrioventricular block complete
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 15.1
stats
group Id
EG000
num Affected
1
num At Risk
153
group Id
EG001
num Affected
2
num At Risk
157
term
Cardiac arrest

time Frame

From randomization through the final analysis data cutoff with range of follow-up time of 0.4 - 138.3 weeks with median of 10.7 weeks in Best Supportive Care arm, and 0.3 - 138.4 weeks with median of 16.3 weeks in carfilzomib arm

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Preserved source evidence · Not medical advice