NCT00004088 · ADVERSE EVENTS

Adverse events

Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma · Source last updated 2019-07-02

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: From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.
Other-event reporting threshold: 0%

When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
HD Chemo Followed by PBPC Rescue Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover. filgrastim recombinant interferon alfa busulfan cyclophosphamide melphalan pamidronate disodium thalidomide peripheral blood stem cell transplantation	0 / 68	68 / 68	23 / 68

Group identifiers: EG000: HD Chemo Followed by PBPC Rescue

Serious adverse events

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

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
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
68
num Events
20
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
68
num Events
18
term
Leukocytes (total WBC) for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
3
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
68
num Events
30
term
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
68
num Events
24
term
Platelets for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
68
num Events
11
term
Transfusion: Platelets for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
6
num At Risk
68
num Events
9
term
Transfusion: pRBCs for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
INR (International Normalized Ratio of prothrombin time)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
2
term
PTT (Partial Thromboplastin Time)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
68
num Events
3
term
Supraventricular and nodal arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Vasovagal episode

Complete source fields

description

When evaluating a toxicity, a modified National Cancer Institute (NCI) autologous bone marrow toxicity scale will be used.

event Groups

deaths Num Affected
23
deaths Num At Risk
68
description
Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover. filgrastim recombinant interferon alfa busulfan cyclophosphamide melphalan pamidronate disodium thalidomide peripheral blood stem cell transplantation
id
EG000
other Num Affected
68
other Num At Risk
68
serious Num Affected
0
serious Num At Risk
68
title
HD Chemo Followed by PBPC Rescue

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
68
num Events
20
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
68
num Events
18
term
Leukocytes (total WBC) for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
3
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
68
num Events
30
term
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
68
num Events
24
term
Platelets for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
68
num Events
11
term
Transfusion: Platelets for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
6
num At Risk
68
num Events
9
term
Transfusion: pRBCs for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
INR (International Normalized Ratio of prothrombin time)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
2
term
PTT (Partial Thromboplastin Time)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
68
num Events
3
term
Supraventricular and nodal arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
68
num Events
1
term
Vasovagal episode

time Frame

From initial high dose (HD) chemotherapy up to three years post-initial HD chemotherapy, or death, or date taken off-study.

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

Preserved source evidence · Not medical advice