NCT01672736 · ADVERSE EVENTS

Adverse events

A Trial of ASP7487 (OSI-906) in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma · Source last updated 2018-09-13

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: 4 years and 10 months. This period includes the time period from study activation to the final data analysis, the results of which are presented here.The adverse event data was collected from study activation on 3 Oct 2012 up to 22 Aug 2017.
Other-event reporting threshold: 5%

Adverse Events were graded in accordance with CTCAE v4.03

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
ASP7487, Velcade, Dexamethasone ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg ASP7487, Velcade, Dexamethasone: ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration	8 / 19	19 / 19	2 / 19

Group identifiers: EG000: ASP7487, Velcade, 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
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Alanine Aminitransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Occured in the same patient with increased Alanine Aminotransferase
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Asparate Aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
not related to study drug
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Death due to progressive disease
organ System
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Death due to multiple myeloma
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Probably related to bortezomib
organ System
Cardiac disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
dyspnea

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
CTCAE v4.03
stats
group Id
EG000
num Affected
7
num At Risk
19
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
7
num At Risk
19
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
8
num At Risk
19
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
7
num At Risk
19
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
4
num At Risk
19
term
Pneumonia/influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
8
num At Risk
19
term
Creatinine Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
13
num At Risk
19
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
3
num At Risk
19
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
4
num At Risk
19
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
6
num At Risk
19
term
Neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
6
num At Risk
19
term
Cough

Complete source fields

description

Adverse Events were graded in accordance with CTCAE v4.03

event Groups

deaths Num Affected
2
deaths Num At Risk
19
description
ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg ASP7487, Velcade, Dexamethasone: ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration
id
EG000
other Num Affected
19
other Num At Risk
19
serious Num Affected
8
serious Num At Risk
19
title
ASP7487, Velcade, Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
7
num At Risk
19
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
7
num At Risk
19
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
8
num At Risk
19
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
7
num At Risk
19
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
4
num At Risk
19
term
Pneumonia/influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
8
num At Risk
19
term
Creatinine Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
13
num At Risk
19
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
3
num At Risk
19
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
4
num At Risk
19
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
6
num At Risk
19
term
Neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
6
num At Risk
19
term
Cough

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Alanine Aminitransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Occured in the same patient with increased Alanine Aminotransferase
organ System
Investigations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Asparate Aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
not related to study drug
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Death due to progressive disease
organ System
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Death due to multiple myeloma
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Probably related to bortezomib
organ System
Cardiac disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
2
num At Risk
19
num Events
2
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.03
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
term
dyspnea

time Frame

4 years and 10 months. This period includes the time period from study activation to the final data analysis, the results of which are presented here.The adverse event data was collected from study activation on 3 Oct 2012 up to 22 Aug 2017.

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Preserved source evidence · Not medical advice