NCT00858234 · ADVERSE EVENTS

Adverse events

Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098) · Source last updated 2021-04-09

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 346 days (up to 30 days after the final dose of study treatment)
Other-event reporting threshold: 0%

All treated participants are included.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Vorinostat + Bortezomib Participants undergo ≤3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.3 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11).	3 / 9	9 / 9	0 / 9

Group identifiers: EG000: Vorinostat + Bortezomib

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 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
2
num At Risk
9
num Events
2
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Pyelonephritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Decreased appetite

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 13.1
stats
group Id
EG000
num Affected
3
num At Risk
9
num Events
8
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
9
num At Risk
9
num Events
98
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
6
num At Risk
9
num Events
32
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
9
num At Risk
9
num Events
99
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
9
num At Risk
9
num Events
189
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
6
num At Risk
9
num Events
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
9
num At Risk
9
num Events
44
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Gingival bleeding

Complete source fields

description

All treated participants are included.

event Groups

deaths Num Affected
0
deaths Num At Risk
9
description
Participants undergo ≤3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.3 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11).
id
EG000
other Num Affected
9
other Num At Risk
9
serious Num Affected
3
serious Num At Risk
9
title
Vorinostat + Bortezomib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
3
num At Risk
9
num Events
8
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
9
num At Risk
9
num Events
98
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
6
num At Risk
9
num Events
32
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
9
num At Risk
9
num Events
99
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
9
num At Risk
9
num Events
189
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
6
num At Risk
9
num Events
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
9
num At Risk
9
num Events
44
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Gingival bleeding

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
2
num At Risk
9
num Events
2
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Pyelonephritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 13.1
stats
group Id
EG000
num Affected
1
num At Risk
9
num Events
1
term
Decreased appetite

time Frame

Up to 346 days (up to 30 days after the final dose of study treatment)

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Preserved source evidence · Not medical advice