NCT01527045 · ADVERSE EVENTS

Adverse events

Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies · Source last updated 2020-01-02

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%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	1 / 29	6 / 29	8 / 29
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.	0 / 5	1 / 5	2 / 5
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.	0 / 12	2 / 12	3 / 12

Group identifiers: EG000: Primary - Reg A (Flu/TBI) · EG001: Primary - Reg B (TBI Alone) · EG002: Adjunct

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
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Duodenal ulcer

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Hypertriglyceridemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Leukoencephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
term
Nausea

Complete source fields

event Groups

deaths Num Affected
8
deaths Num At Risk
29
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
EG000
other Num Affected
6
other Num At Risk
29
serious Num Affected
1
serious Num At Risk
29
title
Primary - Reg A (Flu/TBI)
deaths Num Affected
2
deaths Num At Risk
5
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
EG001
other Num Affected
1
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
Primary - Reg B (TBI Alone)
deaths Num Affected
3
deaths Num At Risk
12
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
EG002
other Num Affected
2
other Num At Risk
12
serious Num Affected
0
serious Num At Risk
12
title
Adjunct

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Hypertriglyceridemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Leukoencephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
12
num Events
1
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
12
num Events
0
term
Duodenal ulcer

time Frame

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

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

Preserved source evidence · Not medical advice