NCT00177047 · ADVERSE EVENTS

Adverse events

Autologous Transplant for Multiple Myeloma · Source last updated 2021-11-09

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: 3 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Chemotherapy and Transplant Treatment Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate. Stem Cell Transplant: As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. Cyclophosphamide + Mesna: Cyclophosphamide: 4mg/m\^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs. Melphalan: Administered intravenously 200 mg/m\^2 Granulocyte-colony stimulating factor: Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.	2 / 363	194 / 363	62 / 363

Group identifiers: EG000: Chemotherapy and Transplant Treatment

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
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
1
term
M-spike increase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
1
term
GI bleeding

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
Renal and urinary disorders
stats
group Id
EG000
num Affected
4
num At Risk
363
num Events
4
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
1
term
Akinesis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
2
num At Risk
363
num Events
2
term
Edema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
2
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
8
num At Risk
363
num Events
8
term
Artrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
1
term
Atelectasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
3
num At Risk
363
num Events
3
term
Blood clot
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
363
num Events
5
term
bowl obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
363
num Events
2
term
Cardiomyopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
4
num At Risk
363
num Events
4
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
3
term
Chest opacities
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
1
term
Cholecystectomy

Complete source fields

event Groups

deaths Num Affected
62
deaths Num At Risk
363
description
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate. Stem Cell Transplant: As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. Cyclophosphamide + Mesna: Cyclophosphamide: 4mg/m\^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs. Melphalan: Administered intravenously 200 mg/m\^2 Granulocyte-colony stimulating factor: Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.
id
EG000
other Num Affected
194
other Num At Risk
363
serious Num Affected
2
serious Num At Risk
363
title
Chemotherapy and Transplant Treatment

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
4
num At Risk
363
num Events
4
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
1
term
Akinesis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
2
num At Risk
363
num Events
2
term
Edema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
2
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
8
num At Risk
363
num Events
8
term
Artrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
1
term
Atelectasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
3
num At Risk
363
num Events
3
term
Blood clot
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
363
num Events
5
term
bowl obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
363
num Events
2
term
Cardiomyopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
4
num At Risk
363
num Events
4
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
3
term
Chest opacities
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
1
term
Cholecystectomy

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
1
term
M-spike increase
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
363
num Events
1
term
GI bleeding

time Frame

3 years

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Preserved source evidence · Not medical advice