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NCT00397813 · STUDY IN CONTEXT

Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disor

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

HCT failure will be defined as graft rejection (defined as \< 5% donor T-cell chimerism) or disease progression within 200 days of transplant.

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

secondary · POSTED

Number of patients who experienced bacterial, fungal, or viral infections.

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

secondary · POSTED

Continued engraftment will be defined as the detection of donor T-cells (CD3+) as a proportion of the total T-cell of greater than 5%.

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

secondary · POSTED

Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.

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

secondary · POSTED

Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.

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

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-myeloproliferative-neoplasms
nct id: NCT00397813
trial label: Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disor
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 5
harms Count: 6
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0000
source section id
NCT00397813-om-0000
source outcome index
0
endpoint
Number of Patients With HCT Failure.
endpoint definition
HCT failure will be defined as graft rejection (defined as \< 5% donor T-cell chimerism) or disease progression within 200 days of transplant.
time origin
200 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0001
source section id
NCT00397813-om-0001
source outcome index
1
endpoint
Number of Patients Who Had Infections
endpoint definition
Number of patients who experienced bacterial, fungal, or viral infections.
time origin
1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0002
source section id
NCT00397813-om-0002
source outcome index
2
endpoint
Number of Patients Who Engrafted
endpoint definition
Continued engraftment will be defined as the detection of donor T-cells (CD3+) as a proportion of the total T-cell of greater than 5%.
time origin
1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0003
source section id
NCT00397813-om-0003
source outcome index
3
endpoint
Number of Patients With Progression-free Survival
endpoint definition
Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.
time origin
1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0004
source section id
NCT00397813-om-0004
source outcome index
4
endpoint
Number of Patients With Relapse/Progression
endpoint definition
Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia.
time origin
1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0000
arm key
OG000
arm label
Arm A - Dose Level 1
regimen
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.
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0000
arm key
OG001
arm label
Arm A - Dose Level 2
regimen
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.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0000
arm key
OG002
arm label
Arm A - Dose Level 3
regimen
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.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0000
arm key
OG003
arm label
Arm B - Dose Level 1
regimen
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.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0000
arm key
OG004
arm label
Arm B - Dose Level 2
regimen
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.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0000
arm key
OG005
arm label
Arm B - Dose Level 3
regimen
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.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0001
arm key
OG000
arm label
Arm A - Dose Level 1
regimen
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.
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0001
arm key
OG001
arm label
Arm A - Dose Level 2
regimen
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.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0001
arm key
OG002
arm label
Arm A - Dose Level 3
regimen
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.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0001
arm key
OG003
arm label
Arm B - Dose Level 1
regimen
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.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0001
arm key
OG004
arm label
Arm B - Dose Level 2
regimen
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.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
outcome key
om-0001
arm key
OG005
arm label
Arm B - Dose Level 3
regimen
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.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00397813-om-0001#groups/OG005

harms

release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
harm key
EG000
source section id
NCT00397813-ae
event group key
EG000
event group label
Arm A - Dose Level 1
serious affected
3
serious at risk
36
other affected
16
other at risk
36
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
event definition
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
harm key
EG001
source section id
NCT00397813-ae
event group key
EG001
event group label
Arm A - Dose Level 2
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
event definition
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
harm key
EG002
source section id
NCT00397813-ae
event group key
EG002
event group label
Arm A - Dose Level 3
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
event definition
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
harm key
EG003
source section id
NCT00397813-ae
event group key
EG003
event group label
Arm B - Dose Level 1
serious affected
7
serious at risk
12
other affected
9
other at risk
12
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
event definition
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
harm key
EG004
source section id
NCT00397813-ae
event group key
EG004
event group label
Arm B - Dose Level 2
serious affected
2
serious at risk
5
other affected
2
other at risk
5
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
event definition
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myeloproliferative-neoplasms
nct id
NCT00397813
harm key
EG005
source section id
NCT00397813-ae
event group key
EG005
event group label
Arm B - Dose Level 3
serious affected
4
serious at risk
24
other affected
13
other at risk
24
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
event definition
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice