TriangleNCT01527045 · OUTCOME
Number of Donors Discontinuing Atorvastatin Due to Toxicity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Prior to stem cell collection
What was measured
The number of donors who prematurely discontinue atorvastatin therapy due to toxicity. Donors will be assessed for the following events: * Musculoskeletal and connective tissue disorders: grade 2-5 * Hepatobiliary disorders: grade 2-5 * Other unexpected events thought related to the use of atorvastatin; grade 2-5 In cases where the NCI criteria do not apply, intensity will be defined as: * Mild: awareness of symptom or sign, but easily tolerated * Moderate: discomfort is enough to cause interference with normal activities * Severe: inability to perform normal daily activities * Life threatening: immediate risk of death from the reaction as it occurred
Groups in this outcome
Primary - Reg A (Flu/TBI)
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.
Primary - Reg B (TBI Alone)
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.
Adjunct
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.
| Group | Source count |
|---|---|
| Primary - Reg A (Flu/TBI) | 30 |
| Primary - Reg B (TBI Alone) | 5 |
| Adjunct | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Primary - Reg A (Flu/TBI) | 2 | Not reported | Not reported | Not reported | Not reported |
| Primary - Reg B (TBI Alone) | 0 | Not reported | Not reported | Not reported | Not reported |
| Adjunct | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 12
- units
- Participants
- description
- The number of donors who prematurely discontinue atorvastatin therapy due to toxicity. Donors will be assessed for the following events: * Musculoskeletal and connective tissue disorders: grade 2-5 * Hepatobiliary disorders: grade 2-5 * Other unexpected events thought related to the use of atorvastatin; grade 2-5 In cases where the NCI criteria do not apply, intensity will be defined as: * Mild: awareness of symptom or sign, but easily tolerated * Moderate: discomfort is enough to cause interference with normal activities * Severe: inability to perform normal daily activities * Life threatening: immediate risk of death from the reaction as it occurred
- groups
- description
- 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.
- id
- OG000
- title
- Primary - Reg A (Flu/TBI)
- description
- 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.
- id
- OG001
- title
- Primary - Reg B (TBI Alone)
- description
- 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.
- id
- OG002
- title
- Adjunct
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Prior to stem cell collection
- title
- Number of Donors Discontinuing Atorvastatin Due to Toxicity
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice