NCT00432094 · ADVERSE EVENTS

Adverse events

Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors · Source last updated 2022-05-17

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: All-Cause Mortality monitored/assessed for 1 year. Serious and Other (Not Including Serious) Adverse Events monitored/assessed for 100 days after cell infusion.
Other-event reporting threshold: 0%

This trial is single arm study and it is non-randomized. Overall, if patients did not have enough cells to do two transplants then they only received one transplants. This trial is not a two arm protocol.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
2 Transplants/1 Transplant Arms (Overall) Patients with Germ Cell Tumors (GCT) treated with one and second autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. Adverse events are not separable by number of transplants because they were not recorded in to the University of Minnesota's CTMS system. Below you will see AEs for patients with 1 and 2 transplants pooled together.	8 / 23	0 / 23	6 / 23

Group identifiers: EG000: 2 Transplants/1 Transplant Arms (Overall)

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
6
num At Risk
23
num Events
7
term
Relapse
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
23
num Events
3
term
Progressive Disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
term
Death

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

event Groups

deaths Num Affected
6
deaths Num At Risk
23
description
Patients with Germ Cell Tumors (GCT) treated with one and second autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. Adverse events are not separable by number of transplants because they were not recorded in to the University of Minnesota's CTMS system. Below you will see AEs for patients with 1 and 2 transplants pooled together.
id
EG000
other Num Affected
0
other Num At Risk
23
serious Num Affected
8
serious Num At Risk
23
title
2 Transplants/1 Transplant Arms (Overall)

frequency Threshold

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
6
num At Risk
23
num Events
7
term
Relapse
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
23
num Events
3
term
Progressive Disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
term
Death

time Frame

All-Cause Mortality monitored/assessed for 1 year. Serious and Other (Not Including Serious) Adverse Events monitored/assessed for 100 days after cell infusion.

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

Preserved source evidence · Not medical advice