Trial Outcomes & Findings for IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome (NCT NCT00469144)
NCT ID: NCT00469144
Last Updated: 2021-01-19
Results Overview
Time to failure (TTF) defined as either disease recurrence or death, from the time of bone marrow transplant (BMT) and reported as TRM at 100 days and 1 year. Treatment period defined as BMT Day -9 for patients treated on the PK-guided treatment arm, and day -7 for patients receiving the fixed-dose busulfan treatment through BMT Day +28. The post study surveillance period is defined as BMT Day +29 through BMT Day +100. Bone marrow aspirate with cytogenetics at approximately one (1) month and three (3) months, or as clinically indicated. Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
233 participants
Primary outcome timeframe
From transplant at Day 0 to Day 100 and 1 year following transplant
Results posted on
2021-01-19
Participant Flow
Recruitment Period: June 28, 2005 to May 12, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.
A total of 233 participants were enrolled, out of which 8 participants withdrew from study prior to treatment and are not evaluable on protocol.
Participant milestones
| Measure |
Fixed-Dose Busulfan + Fludarabine
Busulfan Fixed Dose = 130 mg/m\^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
|
Adjusted Dose Busulfan + Fludarabine
Busulfan Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
111
|
|
Overall Study
COMPLETED
|
108
|
105
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Fixed-Dose Busulfan + Fludarabine
Busulfan Fixed Dose = 130 mg/m\^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
|
Adjusted Dose Busulfan + Fludarabine
Busulfan Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
No Response
|
5
|
5
|
|
Overall Study
Progressive Disease
|
1
|
0
|
Baseline Characteristics
IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
Baseline characteristics by cohort
| Measure |
Fixed-Dose Busulfan + Fludarabine
n=114 Participants
Busulfan Fixed Dose = 130 mg/m\^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
|
Adjusted Dose Busulfan + Fludarabine
n=111 Participants
Busulfan Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
50 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
111 participants
n=7 Participants
|
225 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From transplant at Day 0 to Day 100 and 1 year following transplantTime to failure (TTF) defined as either disease recurrence or death, from the time of bone marrow transplant (BMT) and reported as TRM at 100 days and 1 year. Treatment period defined as BMT Day -9 for patients treated on the PK-guided treatment arm, and day -7 for patients receiving the fixed-dose busulfan treatment through BMT Day +28. The post study surveillance period is defined as BMT Day +29 through BMT Day +100. Bone marrow aspirate with cytogenetics at approximately one (1) month and three (3) months, or as clinically indicated. Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response.
Outcome measures
| Measure |
Fixed-Dose: Participants in CR
n=68 Participants
Busulfan Fixed Dose = 130 mg/m\^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
|
Adjusted Dose: Participants in CR
n=71 Participants
Busulfan Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
|
Fixed Dose: Participants Not in CR
n=46 Participants
Busulfan Fixed Dose = 130 mg/m\^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
|
Adjusted Dose: Participants Not in CR
n=40 Participants
Busulfan Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
|
|---|---|---|---|---|
|
Treatment-related Mortality (TRM)
100 Days
|
3 Percentage of Participants
Interval 1.0 to 11.0
|
3 Percentage of Participants
Interval 1.0 to 11.0
|
7 Percentage of Participants
Interval 2.0 to 20.0
|
3 Percentage of Participants
Interval 0.5 to 17.0
|
|
Treatment-related Mortality (TRM)
1 Year
|
19 Percentage of Participants
Interval 11.0 to 32.0
|
17 Percentage of Participants
Interval 10.0 to 29.0
|
18 Percentage of Participants
Interval 10.0 to 34.0
|
3 Percentage of Participants
Interval 0.5 to 17.0
|
PRIMARY outcome
Timeframe: 3 yearsPFS defined as length of time either due to disease recurrence or death, from the time of stem cell infusion (Bone marrow or PBPC) to 3 years. Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response.
Outcome measures
| Measure |
Fixed-Dose: Participants in CR
n=114 Participants
Busulfan Fixed Dose = 130 mg/m\^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
|
Adjusted Dose: Participants in CR
n=111 Participants
Busulfan Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
|
Fixed Dose: Participants Not in CR
Busulfan Fixed Dose = 130 mg/m\^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
|
Adjusted Dose: Participants Not in CR
Busulfan Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
|
|---|---|---|---|---|
|
3 Year Progression Free Survival
|
42 Days
Interval 32.0 to 52.0
|
56 Days
Interval 45.0 to 66.0
|
—
|
—
|
Adverse Events
Fixed-Dose Busulfan + Fludarabine
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Adjusted Dose Busulfan + Fludarabine
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fixed-Dose Busulfan + Fludarabine
n=114 participants at risk
Busulfan Fixed Dose = 130 mg/m\^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
|
Adjusted Dose Busulfan + Fludarabine
n=111 participants at risk
Busulfan Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
|
|---|---|---|
|
General disorders
Death
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
1.8%
2/111 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Nervous system disorders
Encephalopathy
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
Other adverse events
| Measure |
Fixed-Dose Busulfan + Fludarabine
n=114 participants at risk
Busulfan Fixed Dose = 130 mg/m\^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
|
Adjusted Dose Busulfan + Fludarabine
n=111 participants at risk
Busulfan Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
|
|---|---|---|
|
Gastrointestinal disorders
Chronic Oral GvHD
|
1.8%
2/114 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Beta Hemolytic Streptococcus Upper Respiratory Infection
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Streptococcus Pneumonia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Cytomegalovirus Pneumonia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Respiratory Syncytial Virus Upper Respiratory Infection
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
1.8%
2/111 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Methicillin-Resistant Staphylococcus Aureus Pneumonia
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Influenza A Upper Respiratory Infection
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Eye disorders
Chronic Ocular GvHD
|
2.6%
3/114 • Number of events 3 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Lung GvHD
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Reproductive system and breast disorders
Chronic Vaginal GvHD
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Skin and subcutaneous tissue disorders
Chronic Skin GvHD
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
2.7%
3/111 • Number of events 3 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Eye disorders
Ocular GvHD
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
2.7%
3/111 • Number of events 3 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Infection
|
8.8%
10/114 • Number of events 11 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
4.5%
5/111 • Number of events 5 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Gastrointestinal disorders
Esophageal Dysmotility
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
1.8%
2/111 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Hepatobiliary disorders
Liver GvHD
|
2.6%
3/114 • Number of events 3 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
1.8%
2/111 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Gastrointestinal disorders
Oral GvHD
|
1.8%
2/114 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
1.8%
2/111 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Skin and subcutaneous tissue disorders
Skin GvHD
|
5.3%
6/114 • Number of events 6 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
2/114 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Gastrointestinal disorders
GI GvHD
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Eye disorders
Blurry Vision
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Reproductive system and breast disorders
Vagina GvHD
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Lung GvHD
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Metabolism and nutrition disorders
Bilirubin
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Immune system disorders
Autoimmune Hemolytic Anemia
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
General disorders
Fever
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Surgical and medical procedures
Engraftment Syndrome
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Gastrointestinal disorders
Upper GI GvHD
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
BK Virus
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Aspergillus Pneumonia
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Herpes Simplex Virus
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Influenza B Upper Respiratory Infection
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Cytomegalovirus Reactivation
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
1.8%
2/111 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Micrococcus Line Infection
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Parainfluenza Upper Respiratory Infection
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Pseudomonas Aeruginosa/Enterococcus Urinary Tract Infection
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
1.8%
2/111 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Clostridum Difficile
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Enterococcus Faecalis Line Infection
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Herpes Simplex Virus Esophagitis
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Alpha Hemolytic Strep Line Infection
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Reproductive system and breast disorders
Vulva GvHD
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
2.7%
3/111 • Number of events 3 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Musculoskeletal and connective tissue disorders
Hand-Foot Syndrome
|
0.00%
0/114 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Parainfluenza Pneumonia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Fungal Pneumonia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Influenza A Virus Pneumonia
|
1.8%
2/114 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Herpes Simplex Virus Oral Lesion
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Invasive Candida Glabrata/Fusarium Sinusitis
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Escherichia Coli Urinary Tract Infection
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Branhamella Catarrhalis Upper Respiratory Infection
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Corynebacterium/Bacil/Microbacterium Bacteremia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Stenotrophomonas Maltophilia Bacteremia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Epstein-Barr Virus
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Methicillin-Resistant Staphylococcus Aureus Urinary Tract Infection
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Parvovirus Viremia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Pseudomonas Aeruginosa Bacteremia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Herpes Zoster Eruption
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Bacteremia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.90%
1/111 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Acinetobacter Calcoaceticus Bacteremia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Human Herpes Virus-6
|
1.8%
2/114 • Number of events 2 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Klebsiella Bacteremia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Enterococcus Bacteremia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Acinetobacter Ursingii Bacteremia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Parovirus B19
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Stenotrophomonas (Xanthomonas) Bacteremia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Infections and infestations
Bacillus Species Pneumonia
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Vascular disorders
Periorbital Hemorrhage
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonitis
|
0.88%
1/114 • Number of events 1 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
0.00%
0/111 • Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Overall AE collection period: July 21, 2005 to October 27, 2014.
|
Additional Information
Richard E. Champlin, MD/Chair, Stem Cell Transplantation
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-3618
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place