NCT00983346 · ADVERSE EVENTS

Adverse events

Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients · Source last updated 2016-07-11

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm 1 Bortezomib All participants enrolled. Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle. Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.	2 / 17	17 / 17	Not reported / Not reported

Group identifiers: EG000: Arm 1 Bortezomib

Serious adverse events

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

organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
Obstruction of airway
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
back pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
small bowel obstruction

Other reported adverse events

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

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
17
num Events
2
term
abdomen pain
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
allergic reaction
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
2
term
altered mental status
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
17
num Events
2
term
anxiety
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
3
term
back pain
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
blurred vision
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
3
num At Risk
17
num Events
3
term
bruising
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
Candida albicans
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
cardiomegaly
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
3
num At Risk
17
num Events
3
term
Chest pain
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
cough
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
depression

Complete source fields

event Groups

description
All participants enrolled. Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle. Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.
id
EG000
other Num Affected
17
other Num At Risk
17
serious Num Affected
2
serious Num At Risk
17
title
Arm 1 Bortezomib

frequency Threshold

other Events

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
17
num Events
2
term
abdomen pain
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
allergic reaction
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
2
term
altered mental status
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
17
num Events
2
term
anxiety
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
3
term
back pain
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
blurred vision
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
3
num At Risk
17
num Events
3
term
bruising
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
Candida albicans
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
cardiomegaly
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
3
num At Risk
17
num Events
3
term
Chest pain
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
cough
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
depression

serious Events

organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
Obstruction of airway
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
back pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
17
num Events
1
term
small bowel obstruction

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

Preserved source evidence · Not medical advice