NCT00045305 · ADVERSE EVENTS

Adverse events

Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes · Source last updated 2023-06-28

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: Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Other-event reporting threshold: 5%

Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses. Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient. Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.	17 / 17	17 / 17	Not reported / Not reported

Group identifiers: EG000: Arm I

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
14
num At Risk
17
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Iron overload
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
4
num At Risk
17
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
4
num At Risk
17
term
Diarrhea

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
Ear and labyrinth disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
External ear inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
16
num At Risk
17
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Electrocardiogram QT corrected interval
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
17
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
17
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
17
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Pericardial effusion

Complete source fields

description

event Groups

description
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses. Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient. Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
id
EG000
other Num Affected
17
other Num At Risk
17
serious Num Affected
17
serious Num At Risk
17
title
Arm I

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
External ear inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
16
num At Risk
17
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Electrocardiogram QT corrected interval
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
17
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
17
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
17
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Pericardial effusion

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
14
num At Risk
17
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Iron overload
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
17
num At Risk
17
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
4
num At Risk
17
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
17
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
4
num At Risk
17
term
Diarrhea

time Frame

Assessed at 30 days, 50 days, 100 days and 1 year post transplant

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Preserved source evidence · Not medical advice