NCT00884312 · ADVERSE EVENTS

Adverse events

A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols · Source last updated 2018-05-14

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 first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Other-event reporting threshold: 5%

The protocol indicated that AEs leading to dose modification, dose discontinuation, CTCAE grade 3+, serious AEs and all-grade peripheral neuropathy AEs were collected in the study. 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
Solid Tumors Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.	5 / 9	6 / 9	1 / 9
Multiple Myeloma Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.	57 / 91	69 / 91	7 / 91

Group identifiers: EG000: Solid Tumors · EG001: 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
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
5
num At Risk
91
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Haemolytic uraemic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
2
num At Risk
91
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
3
num At Risk
91
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Coronary artery occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
3
num At Risk
91
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Vertigo

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 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
18
num At Risk
91
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
19
num At Risk
91
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
16
num At Risk
91
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
12
num At Risk
91
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
11
num At Risk
91
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
3
num At Risk
9
group Id
EG001
num Affected
5
num At Risk
91
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Chills

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
9
description
Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
id
EG000
other Num Affected
6
other Num At Risk
9
serious Num Affected
5
serious Num At Risk
9
title
Solid Tumors
deaths Num Affected
7
deaths Num At Risk
91
description
Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
id
EG001
other Num Affected
69
other Num At Risk
91
serious Num Affected
57
serious Num At Risk
91
title
Multiple Myeloma

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
18
num At Risk
91
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
19
num At Risk
91
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
16
num At Risk
91
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
12
num At Risk
91
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
2
num At Risk
9
group Id
EG001
num Affected
11
num At Risk
91
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
3
num At Risk
9
group Id
EG001
num Affected
5
num At Risk
91
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Chills

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
5
num At Risk
91
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Haemolytic uraemic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
2
num At Risk
91
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
3
num At Risk
91
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
1
num At Risk
9
group Id
EG001
num Affected
0
num At Risk
91
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Coronary artery occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
3
num At Risk
91
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 8.1
stats
group Id
EG000
num Affected
0
num At Risk
9
group Id
EG001
num Affected
1
num At Risk
91
term
Vertigo

time Frame

From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.

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