NCT02020941 · ADVERSE EVENTS

Adverse events

Carfilzomib in Treating Patients With Multiple Myeloma in First Relapse or Refractory to First-Line Therapy · Source last updated 2016-11-02

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: up to 2 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Carfilzomib, Dexamethasone) TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8. MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. carfilzomib: Given IV dexamethasone: Given IV or PO laboratory biomarker analysis: Correlative studies	2 / 10	10 / 10	Not reported / Not reported

Group identifiers: EG000: Treatment (Carfilzomib, Dexamethasone)

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
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Heart Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hip fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Pulmonary edema

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
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Heart failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Ear pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Bloating
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Dental caries
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
4
num At Risk
10
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Flatulence

Complete source fields

event Groups

description
TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8. MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. carfilzomib: Given IV dexamethasone: Given IV or PO laboratory biomarker analysis: Correlative studies
id
EG000
other Num Affected
10
other Num At Risk
10
serious Num Affected
2
serious Num At Risk
10
title
Treatment (Carfilzomib, Dexamethasone)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Heart failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Ear pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Conjunctivitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Bloating
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Dental caries
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
4
num At Risk
10
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Flatulence

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Heart Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hip fracture
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Pulmonary edema

time Frame

up to 2 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice