NCT01980589 · ADVERSE EVENTS

Adverse events

A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects · Source last updated 2017-05-30

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 the first dose of study medication until 30 days after the last dose; median duration of treatment was 31 weeks.
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
Carfilzomib 36 mg/m² Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.	0 / 3	3 / 3	Not reported / Not reported
Carfilzomib 45 mg/m² Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.	1 / 3	3 / 3	Not reported / Not reported
Carfilzomib 56 mg/m² Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.	5 / 16	16 / 16	Not reported / Not reported

Group identifiers: EG000: Carfilzomib 36 mg/m² · EG001: Carfilzomib 45 mg/m² · EG002: Carfilzomib 56 mg/m²

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
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
16
term
Coronary artery occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Hypoglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
16
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Pneumonia aspiration

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 19.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
8
num At Risk
16
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
16
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
16
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
6
num At Risk
16
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
4
num At Risk
16
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
16
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
16
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Tachycardia

Complete source fields

description

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

event Groups

description
Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Carfilzomib 36 mg/m²
description
Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Carfilzomib 45 mg/m²
description
Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
id
EG002
other Num Affected
16
other Num At Risk
16
serious Num Affected
5
serious Num At Risk
16
title
Carfilzomib 56 mg/m²

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
8
num At Risk
16
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
16
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
16
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
6
num At Risk
16
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
4
num At Risk
16
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
16
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
16
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Tachycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
16
term
Coronary artery occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Hypoglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
16
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 19.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
16
term
Pneumonia aspiration

time Frame

From the first dose of study medication until 30 days after the last dose; median duration of treatment was 31 weeks.

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