NCT03246906 · ADVERSE EVENTS

Adverse events

Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation · Source last updated 2026-05-14

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: AEs & SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 1 Year.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO	0 / 73	59 / 73	11 / 73
Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclophosphamide: Given IV Cyclosporine: Given PO Sirolimus: Given PO	1 / 72	63 / 72	10 / 72

Group identifiers: EG000: Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) · EG001: Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)

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
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
72
num Events
1
term
Angioedema

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
Renal and urinary disorders
stats
group Id
EG000
num Affected
5
num At Risk
73
num Events
5
group Id
EG001
num Affected
12
num At Risk
72
num Events
12
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
72
num Events
1
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
1
group Id
EG001
num Affected
3
num At Risk
72
num Events
3
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
1
group Id
EG001
num Affected
0
num At Risk
72
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
1
group Id
EG001
num Affected
1
num At Risk
72
num Events
1
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
4
num At Risk
73
num Events
4
group Id
EG001
num Affected
6
num At Risk
72
num Events
6
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
72
num Events
2
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
2
num At Risk
72
num Events
2
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
1
group Id
EG001
num Affected
0
num At Risk
72
num Events
0
term
Aspiration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
4
num At Risk
72
num Events
4
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
72
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
1
group Id
EG001
num Affected
8
num At Risk
72
num Events
9
term
Blood bilirubin increased

Complete source fields

event Groups

deaths Num Affected
11
deaths Num At Risk
73
description
Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
id
EG000
other Num Affected
59
other Num At Risk
73
serious Num Affected
0
serious Num At Risk
73
title
Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)
deaths Num Affected
10
deaths Num At Risk
72
description
Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclophosphamide: Given IV Cyclosporine: Given PO Sirolimus: Given PO
id
EG001
other Num Affected
63
other Num At Risk
72
serious Num Affected
1
serious Num At Risk
72
title
Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
5
num At Risk
73
num Events
5
group Id
EG001
num Affected
12
num At Risk
72
num Events
12
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
72
num Events
1
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
1
group Id
EG001
num Affected
3
num At Risk
72
num Events
3
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
1
group Id
EG001
num Affected
0
num At Risk
72
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
1
group Id
EG001
num Affected
1
num At Risk
72
num Events
1
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
4
num At Risk
73
num Events
4
group Id
EG001
num Affected
6
num At Risk
72
num Events
6
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
72
num Events
2
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
2
num At Risk
72
num Events
2
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
1
group Id
EG001
num Affected
0
num At Risk
72
num Events
0
term
Aspiration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
4
num At Risk
72
num Events
4
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
72
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
73
num Events
1
group Id
EG001
num Affected
8
num At Risk
72
num Events
9
term
Blood bilirubin increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
73
num Events
0
group Id
EG001
num Affected
1
num At Risk
72
num Events
1
term
Angioedema

time Frame

AEs & SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 1 Year.

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

Preserved source evidence · Not medical advice