NCT01036009 · ADVERSE EVENTS

Adverse events

A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies · Source last updated 2016-06-23

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: 2 years
Other-event reporting threshold: 5%

Due to the severity of illness in this patient population, this study collected and reported Adverse Events only if at least possibly related to study participation, and only in patients undergoing study intervention (intervention arm).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group I: Observation Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.	0 / 0	0 / 0	Not reported / Not reported
Group II: Intervention Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.	1 / 26	9 / 26	Not reported / Not reported

Group identifiers: EG000: Group I: Observation · EG001: Group II: Intervention

Serious 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
notes
severe cGVHD that involved lungs, treated with Prednisone, death due to fungal lung infection
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
0
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
intervention-related-death

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
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
0
num Events
0
group Id
EG001
num Affected
3
num At Risk
26
num Events
3
term
aGVHD grade I-III
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
0
num Events
0
group Id
EG001
num Affected
2
num At Risk
26
num Events
2
term
cGVHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
0
num Events
0
group Id
EG001
num Affected
4
num At Risk
26
num Events
4
term
progressive disease

Complete source fields

description

event Groups

description
Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
id
EG000
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Group I: Observation
description
Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.
id
EG001
other Num Affected
9
other Num At Risk
26
serious Num Affected
1
serious Num At Risk
26
title
Group II: Intervention

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
0
num Events
0
group Id
EG001
num Affected
3
num At Risk
26
num Events
3
term
aGVHD grade I-III
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
0
num Events
0
group Id
EG001
num Affected
2
num At Risk
26
num Events
2
term
cGVHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
0
num Events
0
group Id
EG001
num Affected
4
num At Risk
26
num Events
4
term
progressive disease

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
severe cGVHD that involved lungs, treated with Prednisone, death due to fungal lung infection
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
0
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
intervention-related-death

time Frame

2 years

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Preserved source evidence · Not medical advice