NCT00577096 · ADVERSE EVENTS

Adverse events

Effects of Exercise in Combination With Epoetin Alfa · Source last updated 2015-04-06

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: up to 30 weeks
Other-event reporting threshold: 0%

All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Usual Care Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (\<=60 versus \>60).Participants who received thalidomide also received low-molecular weight heparin	17 / 62	0 / 0	Not reported / Not reported
Exercise Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (\<=60 versus \>60). Participants who received thalidomide also received low-molecular weight heparin.	25 / 58	0 / 0	Not reported / Not reported

Group identifiers: EG000: Usual Care · EG001: Exercise

Serious adverse events

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

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Anemia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Atrial fibrillation
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Compression fracture
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Death
organ System
Vascular disorders
stats
group Id
EG000
num Affected
11
num At Risk
62
group Id
EG001
num Affected
10
num At Risk
58
term
Deep Vein Thrombosis (DVT)
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Dehydration
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
58
term
Fluid overload
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
3
num At Risk
62
group Id
EG001
num Affected
3
num At Risk
58
term
Hyperglycemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
5
num At Risk
58
term
Hyponatremia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
5
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Infection / sepsis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Mucositis / diarrhea
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Myocardial infarction

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

description

All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.

event Groups

description
Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (\<=60 versus \>60).Participants who received thalidomide also received low-molecular weight heparin
id
EG000
other Num Affected
0
other Num At Risk
0
serious Num Affected
17
serious Num At Risk
62
title
Usual Care
description
Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (\<=60 versus \>60). Participants who received thalidomide also received low-molecular weight heparin.
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
25
serious Num At Risk
58
title
Exercise

frequency Threshold

serious Events

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Anemia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Atrial fibrillation
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Compression fracture
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Death
organ System
Vascular disorders
stats
group Id
EG000
num Affected
11
num At Risk
62
group Id
EG001
num Affected
10
num At Risk
58
term
Deep Vein Thrombosis (DVT)
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Dehydration
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
58
term
Fluid overload
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
3
num At Risk
62
group Id
EG001
num Affected
3
num At Risk
58
term
Hyperglycemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
5
num At Risk
58
term
Hyponatremia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
5
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Infection / sepsis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Mucositis / diarrhea
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
58
term
Myocardial infarction

time Frame

up to 30 weeks

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

Preserved source evidence · Not medical advice