NCT01090921 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma · Source last updated 2020-09-09

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: Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bortezomib and Dexamethasone Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks. Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.	28 / 50	0 / 50	6 / 50

Group identifiers: EG000: Bortezomib and 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
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
9
num At Risk
50
num Events
9
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
term
Vomiting/Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
term
Elevated creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
term
Acute renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
50
num Events
4
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
9
num At Risk
50
num Events
9
term
Hyperglycemia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

event Groups

deaths Num Affected
6
deaths Num At Risk
50
description
Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks. Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.
id
EG000
other Num Affected
0
other Num At Risk
50
serious Num Affected
28
serious Num At Risk
50
title
Bortezomib and Dexamethasone

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
9
num At Risk
50
num Events
9
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
term
Vomiting/Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
50
num Events
1
term
Elevated creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
2
num At Risk
50
num Events
2
term
Acute renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
50
num Events
4
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
9
num At Risk
50
num Events
9
term
Hyperglycemia

time Frame

Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.

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Preserved source evidence · Not medical advice