NCT01351623 · ADVERSE EVENTS

Adverse events

Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2017-04-13

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
Carfilzomib A single arm, open-label, single institution phase 2 clinical trial is planned. Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.	28 / 44	44 / 44	Not reported / Not reported

Group identifiers: EG000: 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
Infections and infestations
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Abdominal Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
4
num At Risk
44
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
3
num At Risk
44
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
2
num At Risk
44
term
Blood and lymphatic system disorders - Other, spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Bronchopulmonary hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Participants expired due to progression of disease
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
4
num At Risk
44
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
5
num At Risk
44
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
2
num At Risk
44
term
Febrile neutropenia

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-4.0
stats
group Id
EG000
num Affected
29
num At Risk
44
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
26
num At Risk
44
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
24
num At Risk
44
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
23
num At Risk
44
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
22
num At Risk
44
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
18
num At Risk
44
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
17
num At Risk
44
term
Peripheral edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
16
num At Risk
44
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
16
num At Risk
44
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
16
num At Risk
44
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
12
num At Risk
44
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
11
num At Risk
44
term
Heart failure

Complete source fields

event Groups

description
A single arm, open-label, single institution phase 2 clinical trial is planned. Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.
id
EG000
other Num Affected
44
other Num At Risk
44
serious Num Affected
28
serious Num At Risk
44
title
Carfilzomib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
29
num At Risk
44
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
26
num At Risk
44
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
24
num At Risk
44
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
23
num At Risk
44
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
22
num At Risk
44
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
18
num At Risk
44
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
17
num At Risk
44
term
Peripheral edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
16
num At Risk
44
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
16
num At Risk
44
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
16
num At Risk
44
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
12
num At Risk
44
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
11
num At Risk
44
term
Heart failure

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Abdominal Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
4
num At Risk
44
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
3
num At Risk
44
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
2
num At Risk
44
term
Blood and lymphatic system disorders - Other, spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Bronchopulmonary hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Participants expired due to progression of disease
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
4
num At Risk
44
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
1
num At Risk
44
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
5
num At Risk
44
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-4.0
stats
group Id
EG000
num Affected
2
num At Risk
44
term
Febrile neutropenia

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