NCT00118352 · ADVERSE EVENTS

Adverse events

Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2017-05-30

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
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Level 1 (No Campath) Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	2 / 12	7 / 12	Not reported / Not reported
Dose Level 2 (40mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	0 / 0	0 / 0	Not reported / Not reported
Dose Level 3 (60mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	0 / 0	0 / 0	Not reported / Not reported

Group identifiers: EG000: Dose Level 1 (No Campath) · EG001: Dose Level 2 (40mg Total Dose Campath) · EG002: Dose Level 3 (60mg Total Dose Campath)

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
notes
Concurrent elevated bilirubin. Patient expired
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Death due to GVHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Abdominal pain

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
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
4
num At Risk
12
num Events
4
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
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Peripheral motor neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Ventricular arrhythmia

Complete source fields

event Groups

description
Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
id
EG000
other Num Affected
7
other Num At Risk
12
serious Num Affected
2
serious Num At Risk
12
title
Dose Level 1 (No Campath)
description
Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Dose Level 2 (40mg Total Dose Campath)
description
Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
id
EG002
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Dose Level 3 (60mg Total Dose Campath)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
4
num At Risk
12
num Events
4
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
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Peripheral motor neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Ventricular arrhythmia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Concurrent elevated bilirubin. Patient expired
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Death due to GVHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
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
term
Abdominal pain

time Frame

AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200

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Preserved source evidence · Not medical advice