NCT00397813 · ADVERSE EVENTS

Adverse events

Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders · Source last updated 2020-01-31

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: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
Other-event reporting threshold: 0%

No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A - Dose Level 1 Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.	3 / 36	16 / 36	10 / 36
Arm A - Dose Level 2 Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.	0 / 0	0 / 0	0 / 0
Arm A - Dose Level 3 Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.	0 / 0	0 / 0	0 / 0
Arm B - Dose Level 1 Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.	7 / 12	9 / 12	10 / 12
Arm B - Dose Level 2 Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.	2 / 5	2 / 5	3 / 5
Arm B - Dose Level 3 Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.	4 / 24	13 / 24	9 / 24

Group identifiers: EG000: Arm A - Dose Level 1 · EG001: Arm A - Dose Level 2 · EG002: Arm A - Dose Level 3 · EG003: Arm B - Dose Level 1 · EG004: Arm B - Dose Level 2 · EG005: Arm B - Dose Level 3

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
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
GVHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Mucosal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
2
num At Risk
12
num Events
2
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
2
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Psychiatric disorders - Other, specify (altered mental status)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Respiratory Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Seizure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Suicide attempt

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
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
2
num At Risk
24
num Events
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
2
num At Risk
24
num Events
2
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Blood antidiuretic hormone abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
9
num At Risk
36
num Events
11
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
3
num At Risk
12
num Events
3
group Id
EG004
num Affected
2
num At Risk
5
num Events
2
group Id
EG005
num Affected
6
num At Risk
24
num Events
6
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Carbon monoxide diffusing capacity decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
num Events
2
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Esophagitis

Complete source fields

description

No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.

event Groups

deaths Num Affected
10
deaths Num At Risk
36
description
Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
id
EG000
other Num Affected
16
other Num At Risk
36
serious Num Affected
3
serious Num At Risk
36
title
Arm A - Dose Level 1
deaths Num Affected
0
deaths Num At Risk
0
description
Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Arm A - Dose Level 2
deaths Num Affected
0
deaths Num At Risk
0
description
Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
id
EG002
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Arm A - Dose Level 3
deaths Num Affected
10
deaths Num At Risk
12
description
Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
id
EG003
other Num Affected
9
other Num At Risk
12
serious Num Affected
7
serious Num At Risk
12
title
Arm B - Dose Level 1
deaths Num Affected
3
deaths Num At Risk
5
description
Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
id
EG004
other Num Affected
2
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Arm B - Dose Level 2
deaths Num Affected
9
deaths Num At Risk
24
description
Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
id
EG005
other Num Affected
13
other Num At Risk
24
serious Num Affected
4
serious Num At Risk
24
title
Arm B - Dose Level 3

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
2
num At Risk
24
num Events
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
2
num At Risk
24
num Events
2
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Blood antidiuretic hormone abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
9
num At Risk
36
num Events
11
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
3
num At Risk
12
num Events
3
group Id
EG004
num Affected
2
num At Risk
5
num Events
2
group Id
EG005
num Affected
6
num At Risk
24
num Events
6
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Carbon monoxide diffusing capacity decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
num Events
2
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Esophagitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
GVHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
1
num At Risk
5
num Events
1
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Mucosal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
2
num At Risk
12
num Events
2
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
2
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Psychiatric disorders - Other, specify (altered mental status)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
1
num At Risk
12
num Events
1
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Respiratory Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
1
num At Risk
24
num Events
1
term
Seizure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
0
num Events
0
group Id
EG002
num Affected
0
num At Risk
0
num Events
0
group Id
EG003
num Affected
0
num At Risk
12
num Events
0
group Id
EG004
num Affected
0
num At Risk
5
num Events
0
group Id
EG005
num Affected
0
num At Risk
24
num Events
0
term
Suicide attempt

time Frame

AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.

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Preserved source evidence · Not medical advice