NCT00718640 · ADVERSE EVENTS

Adverse events

An Efficacy and Safety Study of Bortezomib in Participants Previously Treated for Multiple Myeloma With Limited Kidney Function · Source last updated 2013-10-29

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: Day 1 up to 30 days after last dose of study medication
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bortezomib and Dexamethasone Bortezomib 1.3 milligram (mg) per meter\^2 (m\^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).	4 / 10	9 / 10	Not reported / Not reported

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Renal impairment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Muscle weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Depressed level of consciousness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Aphasia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Speech disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Confusion state
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Gastrointestinal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Dehydration

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
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Orthostatic hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Mood altered
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Confusional state
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Peripheral sensory neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Neuropathy peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Neuralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Muscular weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Hypokalaemia

Complete source fields

event Groups

description
Bortezomib 1.3 milligram (mg) per meter\^2 (m\^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
id
EG000
other Num Affected
9
other Num At Risk
10
serious Num Affected
4
serious Num At Risk
10
title
Bortezomib and Dexamethasone

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Orthostatic hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Mood altered
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Confusional state
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Peripheral sensory neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Neuropathy peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Neuralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Muscular weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
10
term
Hypokalaemia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Renal impairment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Muscle weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Depressed level of consciousness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Aphasia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Speech disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Confusion state
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Gastrointestinal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
10
term
Dehydration

time Frame

Day 1 up to 30 days after last dose of study medication

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Preserved source evidence · Not medical advice