TriangleNCT01527045 · STUDY IN CONTEXT
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
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
Number of patients who developed acute GVHD post allogeneic transplant. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
Number of patients who developed acute GVHD post allogeneic transplant. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
Number of patients requiring systemic immunosuppressive therapy other than those used for prophylaxis and initial therapy.
Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD. Patients were evaluated as described in the National Institutes of Health (NIH) consensus project guidelines.
CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. AML, ALL, MDS \>5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease. CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
Number of patients who died without relapsed/progressive disease.
Reported safety
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-prolymphocytic-leukemia
- nct id
- NCT01527045
- trial label
- Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
- 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
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0000
- source section id
- NCT01527045-om-0000
- source outcome index
- 0
- endpoint
- Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) Post-transplant
- endpoint definition
- Number of patients who developed acute GVHD post allogeneic transplant. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
- time origin
- 100 days post-transplant
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
- 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-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0001
- source section id
- NCT01527045-om-0001
- source outcome index
- 1
- endpoint
- Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD)
- endpoint definition
- Number of patients who developed acute GVHD post allogeneic transplant. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
- time origin
- 100 days post-transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
- 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-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0002
- source section id
- NCT01527045-om-0002
- source outcome index
- 2
- endpoint
- Number of Patients Requiring Secondary Systemic Immunosuppressive Therapy
- endpoint definition
- Number of patients requiring systemic immunosuppressive therapy other than those used for prophylaxis and initial therapy.
- time origin
- 1 Year post-transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
- 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-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0003
- source section id
- NCT01527045-om-0003
- source outcome index
- 3
- endpoint
- Number of Patients With Chronic Extensive GVHD
- endpoint definition
- Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD. Patients were evaluated as described in the National Institutes of Health (NIH) consensus project guidelines.
- time origin
- 1 Year post-transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
- 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-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0004
- source section id
- NCT01527045-om-0004
- source outcome index
- 4
- endpoint
- Number of Patients With Recurrent or Progressive Malignancy
- endpoint definition
- CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. AML, ALL, MDS \>5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease. CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
- time origin
- 1 Year post-transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
- 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-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0005
- source section id
- NCT01527045-om-0005
- source outcome index
- 5
- endpoint
- Number of Non-relapse Mortalities
- endpoint definition
- Number of patients who died without relapsed/progressive disease.
- time origin
- 1 Year post-transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
- 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-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Primary - Reg A (Flu/TBI)
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Primary - Reg B (TBI Alone)
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Adjunct
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Primary - Reg A (Flu/TBI)
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Primary - Reg B (TBI Alone)
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Adjunct
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Primary - Reg A (Flu/TBI)
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Primary - Reg B (TBI Alone)
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Adjunct
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Primary - Reg A (Flu/TBI)
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 (except for patients who had prior autologous HCT or equivalent high-dose therapy without HCT) and undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Primary - Reg B (TBI Alone)
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: Patients will undergo low-dose total body irradiation (TBI) on day 0. TRANSPLANT: Patients undergo donor PBSC transplant on day 0. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Adjunct
- regimen
- NONMYELOABLATIVE PREPARATIVE REGIMEN: The preparative regimen and immunosuppression after transplant will be according to respective protocol or treatment plan. POST-GRAFTING IMMUNOSUPPRESSION: Patients receive CSP PO twice daily (BID) on days -3 to 56 with taper to day 180. Patients also receive mycophenolate mofetil (MMF) PO BID or IV every 12 hours on days 0-27.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01527045-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT01527045
- harm key
- EG000
- source section id
- NCT01527045-ae
- event group key
- EG000
- event group label
- Primary - Reg A (Flu/TBI)
- serious affected
- 1
- serious at risk
- 29
- other affected
- 6
- other at risk
- 29
- frequency threshold
- 0
- collection period
- AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
- event definition
- Source null
- 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-prolymphocytic-leukemia
- nct id
- NCT01527045
- harm key
- EG001
- source section id
- NCT01527045-ae
- event group key
- EG001
- event group label
- Primary - Reg B (TBI Alone)
- serious affected
- 0
- serious at risk
- 5
- other affected
- 1
- 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
- Source null
- 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-prolymphocytic-leukemia
- nct id
- NCT01527045
- harm key
- EG002
- source section id
- NCT01527045-ae
- event group key
- EG002
- event group label
- Adjunct
- serious affected
- 0
- serious at risk
- 12
- other affected
- 2
- 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
- Source null
- 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