NCT00793650 · ADVERSE EVENTS

Adverse events

Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study · Source last updated 2012-08-30

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
Bortezomib Before HD Melphalan All patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2	4 / 19	19 / 19	Not reported / Not reported
Bortezomib After HD melphalanAll patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2	2 / 20	18 / 20	Not reported / Not reported

Group identifiers: EG000: Bortezomib Before HD Melphalan · EG001: Bortezomib After HD melphalanAll

Serious adverse events

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

organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
19
group Id
EG001
num Affected
1
num At Risk
20
term
Expired
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
19
group Id
EG001
num Affected
1
num At Risk
20
term
Acute pulmonary embolus
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
group Id
EG001
num Affected
0
num At Risk
20
term
Hemorrhage/Bleeding-Hemorrhage

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
18
num At Risk
19
group Id
EG001
num Affected
16
num At Risk
20
term
Muscositis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
16
num At Risk
19
group Id
EG001
num Affected
18
num At Risk
20
term
Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
19
num At Risk
19
group Id
EG001
num Affected
18
num At Risk
20
term
Nausea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
11
num At Risk
19
group Id
EG001
num Affected
11
num At Risk
20
term
Vomiting
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
11
num At Risk
19
group Id
EG001
num Affected
13
num At Risk
20
term
Febrile Neutropenia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
3
num At Risk
19
group Id
EG001
num Affected
2
num At Risk
20
term
Sepsis
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
5
num At Risk
19
group Id
EG001
num Affected
4
num At Risk
20
term
Liver Toxicities
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
19
group Id
EG001
num Affected
1
num At Risk
20
term
Clostridium diificile
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
4
num At Risk
19
group Id
EG001
num Affected
7
num At Risk
20
term
Renal toxicities
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
19
group Id
EG001
num Affected
5
num At Risk
20
term
Rash
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
19
group Id
EG001
num Affected
1
num At Risk
20
term
Cognitive disturbances
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
group Id
EG001
num Affected
0
num At Risk
20
term
Seizures

Complete source fields

event Groups

description
All patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
id
EG000
other Num Affected
19
other Num At Risk
19
serious Num Affected
4
serious Num At Risk
19
title
Bortezomib Before HD Melphalan
description
patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
id
EG001
other Num Affected
18
other Num At Risk
20
serious Num Affected
2
serious Num At Risk
20
title
Bortezomib After HD melphalanAll

frequency Threshold

other Events

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
18
num At Risk
19
group Id
EG001
num Affected
16
num At Risk
20
term
Muscositis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
16
num At Risk
19
group Id
EG001
num Affected
18
num At Risk
20
term
Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
19
num At Risk
19
group Id
EG001
num Affected
18
num At Risk
20
term
Nausea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
11
num At Risk
19
group Id
EG001
num Affected
11
num At Risk
20
term
Vomiting
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
11
num At Risk
19
group Id
EG001
num Affected
13
num At Risk
20
term
Febrile Neutropenia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
3
num At Risk
19
group Id
EG001
num Affected
2
num At Risk
20
term
Sepsis
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
5
num At Risk
19
group Id
EG001
num Affected
4
num At Risk
20
term
Liver Toxicities
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
19
group Id
EG001
num Affected
1
num At Risk
20
term
Clostridium diificile
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
4
num At Risk
19
group Id
EG001
num Affected
7
num At Risk
20
term
Renal toxicities
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
19
group Id
EG001
num Affected
5
num At Risk
20
term
Rash
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
19
group Id
EG001
num Affected
1
num At Risk
20
term
Cognitive disturbances
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
group Id
EG001
num Affected
0
num At Risk
20
term
Seizures

serious Events

organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
19
group Id
EG001
num Affected
1
num At Risk
20
term
Expired
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
19
group Id
EG001
num Affected
1
num At Risk
20
term
Acute pulmonary embolus
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
group Id
EG001
num Affected
0
num At Risk
20
term
Hemorrhage/Bleeding-Hemorrhage

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Preserved source evidence · Not medical advice