Trial Outcomes & Findings for Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma (NCT NCT01849783)
NCT ID: NCT01849783
Last Updated: 2022-05-11
Results Overview
PFS is defined as the time from the start of DPACE to the date of first documentation of disease progression as assessed by the International Myeloma Working Group response criteria or death due to any cause. Progression is defined using the International Myeloma Working Group response criteria, an increase of greater than or equal to 25% from the lower response value.
COMPLETED
PHASE2
41 participants
From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.
2022-05-11
Participant Flow
Participant milestones
| Measure |
Autologous Stem Cell Transplant
Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days.
Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.
Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide)
Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.
dexamethasone: Given PO
cisplatin: Given IV
doxorubicin: Given IV
cyclophosphamide: Given IV or PO
etoposide: Given IV
bortezomib: Given IV
thalidomide: Given PO
melphalan: Given IV
autologous stem cell transplant
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Autologous Stem Cell Transplant
Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days.
Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.
Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide)
Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.
dexamethasone: Given PO
cisplatin: Given IV
doxorubicin: Given IV
cyclophosphamide: Given IV or PO
etoposide: Given IV
bortezomib: Given IV
thalidomide: Given PO
melphalan: Given IV
autologous stem cell transplant
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Death
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Unable to comply
|
2
|
|
Overall Study
Disease progression
|
11
|
Baseline Characteristics
Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Autologous Stem Cell Transplant
n=41 Participants
Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days.
Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.
Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide)
Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.
dexamethasone: Given PO
cisplatin: Given IV
doxorubicin: Given IV
cyclophosphamide: Given IV or PO
etoposide: Given IV
bortezomib: Given IV
thalidomide: Given PO
melphalan: Given IV
autologous stem cell transplant
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.Population: Participants who have had at least one day of protocol treatment.
PFS is defined as the time from the start of DPACE to the date of first documentation of disease progression as assessed by the International Myeloma Working Group response criteria or death due to any cause. Progression is defined using the International Myeloma Working Group response criteria, an increase of greater than or equal to 25% from the lower response value.
Outcome measures
| Measure |
Autologous Stem Cell Transplant
n=41 Participants
Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days.
Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.
Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide)
Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.
dexamethasone: Given PO
cisplatin: Given IV
doxorubicin: Given IV
cyclophosphamide: Given IV or PO
etoposide: Given IV
bortezomib: Given IV
thalidomide: Given PO
melphalan: Given IV
autologous stem cell transplant
|
|---|---|
|
Median Progression Free Survival (mPFS)
|
76.4 months
Interval 43.6 to
1-sided 95% confidence interval reported. Study designed to test whether regimen would increase PFS using 1-sided test at 5% significance level. In accordance with statistical hypothesis,1-sided 95% confidence interval is reported. The form does not provide option for 1-sided confidence interval; only options for 2-sided confidence intervals. Since a 1-sided confidence interval only has 1 bound, NA entered for the upper bound because there is no upper bound.
|
PRIMARY outcome
Timeframe: From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.Population: Participants who have had at least one day of protocol treatment
Percentage of participants with severe complications defined at ICU admission and death, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Outcome measures
| Measure |
Autologous Stem Cell Transplant
n=41 Participants
Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days.
Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.
Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide)
Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.
dexamethasone: Given PO
cisplatin: Given IV
doxorubicin: Given IV
cyclophosphamide: Given IV or PO
etoposide: Given IV
bortezomib: Given IV
thalidomide: Given PO
melphalan: Given IV
autologous stem cell transplant
|
|---|---|
|
Percentage of Participants With Serious Treatment-Related Complications
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 6 yearsPopulation: Participants who received at least one day of study treatment
Percentage of participants able to complete the full course of therapy.
Outcome measures
| Measure |
Autologous Stem Cell Transplant
n=41 Participants
Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days.
Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.
Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide)
Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.
dexamethasone: Given PO
cisplatin: Given IV
doxorubicin: Given IV
cyclophosphamide: Given IV or PO
etoposide: Given IV
bortezomib: Given IV
thalidomide: Given PO
melphalan: Given IV
autologous stem cell transplant
|
|---|---|
|
Percentage of Participants Able to Complete Full Course Therapy
|
24 Participants
|
SECONDARY outcome
Timeframe: Pre-DPACE, Pre-maintenance, every 6 months for up to 2 years during maintenance. Up to 6 years.Population: Participants who received at least one day of study treatment. Globally, there were 37 patients who were included in at least one of the estimated mean change scores being reported. Four patients were not included due to not completing the baseline questionnaire making it impossible to calculate change from baseline (n=3) or did not complete the questionnaire at any time point (n=1).
Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement.
Outcome measures
| Measure |
Autologous Stem Cell Transplant
n=37 Participants
Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.
After collection, participants will receive dexamethasone x 4 days every 14 days.
Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.
Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.
Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide)
Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.
dexamethasone: Given PO
cisplatin: Given IV
doxorubicin: Given IV
cyclophosphamide: Given IV or PO
etoposide: Given IV
bortezomib: Given IV
thalidomide: Given PO
melphalan: Given IV
autologous stem cell transplant
|
|---|---|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Physical Functioning at Pre-Maintenance
|
1.3 score on a scale
Interval -5.2 to 7.9
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Physical Functioning at Maintenance Cycle 6
|
-0.6 score on a scale
Interval -7.1 to 5.9
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Physical Functioning at Maintenance Cycle 12
|
1.1 score on a scale
Interval -5.6 to 7.8
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Physical Functioning at Maintenance Cycle 18
|
5.4 score on a scale
Interval -1.5 to 12.3
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Physical Functioning at Maintenance Cycle 24
|
4.6 score on a scale
Interval -2.6 to 11.7
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Role Functioning at Pre-Maintenance
|
7.4 score on a scale
Interval -5.5 to 20.4
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Role Functioning at Maintenance Cycle 6
|
8.7 score on a scale
Interval -4.0 to 21.5
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Role Functioning at Maintenance Cycle 12
|
4.4 score on a scale
Interval -8.7 to 17.5
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Role Functioning at Maintenance Cycle 18
|
7.0 score on a scale
Interval -6.6 to 20.5
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Role Functioning at Maintenance Cycle 24
|
6.0 score on a scale
Interval -8.0 to 20.0
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Emotional Functioning at Pre-Maintenance
|
8.7 score on a scale
Interval 2.5 to 14.9
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Emotional Functioning at Maintenance Cycle 6
|
5.5 score on a scale
Interval -0.6 to 11.6
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Emotional Functioning at Maintenance Cycle 12
|
1.4 score on a scale
Interval -4.9 to 7.7
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Emotional Functioning at Maintenance Cycle 18
|
5.8 score on a scale
Interval -1.0 to 12.5
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Emotional Functioning at Maintenance Cycle 24
|
8.3 score on a scale
Interval 1.3 to 15.2
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Cognitive Functioning at Pre-Maintenance
|
0.4 score on a scale
Interval -7.1 to 7.9
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Cognitive Functioning at Maintenance Cycle 6
|
-4.6 score on a scale
Interval -12.0 to 2.9
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Cognitive Functioning at Maintenance Cycle 12
|
-5.1 score on a scale
Interval -12.8 to 2.5
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Cognitive Functioning at Maintenance Cycle 18
|
-6.0 score on a scale
Interval -14.0 to 2.1
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Cognitive Functioning at Maintenance Cycle 24
|
-3.6 score on a scale
Interval -11.9 to 4.7
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Social Functioning at Pre-Maintenance
|
-1.0 score on a scale
Interval -11.0 to 9.1
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Social Functioning at Maintenance Cycle 6
|
2.7 score on a scale
Interval -7.2 to 12.6
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Social Functioning at Maintenance Cycle 12
|
-4.9 score on a scale
Interval -15.3 to 5.6
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Social Functioning at Maintenance Cycle 18
|
0.8 score on a scale
Interval -9.9 to 11.6
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Social Functioning at Maintenance Cycle 24
|
-1.5 score on a scale
Interval -12.7 to 9.7
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Global Health Status at Pre-Maintenance
|
5.4 score on a scale
Interval -2.7 to 13.5
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Global Health Status at Maintenance Cycle 6
|
0.2 score on a scale
Interval -7.8 to 8.3
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Global Health Status at Maintenance Cycle 12
|
-3.1 score on a scale
Interval -11.4 to 5.1
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Global Health Status at Maintenance Cycle 18
|
-0.1 score on a scale
Interval -8.8 to 8.5
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Global Health Status at Maintenance Cycle 24
|
3.4 score on a scale
Interval -5.6 to 12.3
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Distress Symptoms at Pre-Maintenance
|
6.2 score on a scale
Interval 1.2 to 11.2
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Distress Symptoms at Maintenance Cycle 6
|
5.9 score on a scale
Interval 0.9 to 10.8
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Distress Symptoms at Maintenance Cycle 12
|
5.7 score on a scale
Interval 0.5 to 10.9
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Distress Symptoms at Maintenance Cycle 18
|
3.8 score on a scale
Interval -1.7 to 9.3
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Distress Symptoms at Maintenance Cycle 24
|
5.3 score on a scale
Interval -0.4 to 11.0
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Side Effects of Treatment at Pre-Maintenance
|
-3.3 score on a scale
Interval -8.0 to 1.3
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Side Effects of Treatment at Maintenance Cycle 6
|
-0.7 score on a scale
Interval -5.3 to 3.9
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Side Effects of Treatment at Maintenance Cycle 12
|
-5.1 score on a scale
Interval -9.8 to -0.3
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Side Effects of Treatment at Maintenance Cycle 18
|
-2.4 score on a scale
Interval -7.4 to 2.5
|
|
Mean Change in Quality-Of-Life Indicators Post-Transplant
Change in Side Effects of Treatment at Maintenance Cycle 24
|
-2.7 score on a scale
Interval -7.8 to 2.4
|
Adverse Events
D-PACE/Induction
Post D-PACE/Pre-Transplant
Transplant
Post-transplant/Consolidation
Maintenance Therapy, Year 1
Maintenance Therapy, Year 2
Long Term Follow-up
Serious adverse events
| Measure |
D-PACE/Induction
n=41 participants at risk
Initial chemotherapy will consist of 1 cycle of combination D-PACE chemotherapy and peripheral blood stem cell collection.
|
Post D-PACE/Pre-Transplant
n=41 participants at risk
Following D-PACE and Peripheral Blood Stem Cell (PBSC) collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days, but this may be omitted by the treating physician
|
Transplant
n=39 participants at risk
Transplant should preferably occur 6 weeks after the induction PACE continuous infusion has been completed, but can occur as early as 4 weeks and as late as 3 months if the participant fails to mobilize stem cells after the PACE administration
|
Post-transplant/Consolidation
n=38 participants at risk
Participants will receive dexamethasone 20 mg oral days 1-4 every 21 days and thalidomide 100 mg oral and daily in the interim between transplant and consolidation.
If administered, post-transplant consolidation therapy should begin 4-6 weeks after transplant, but should occur no later than 4 months after transplant. Consolidation will consist of one cycle of VDT-PACE.
|
Maintenance Therapy, Year 1
n=37 participants at risk
Maintenance will begin 4 weeks to 6 months after transplant, or between 6 weeks to 6 months after consolidation if administered. This is considered standard of care
|
Maintenance Therapy, Year 2
n=31 participants at risk
Maintenance will begin 4 weeks to 6 months after transplant, or between 6 weeks to 6 months after consolidation if administered. This is considered standard of care
|
Long Term Follow-up
n=24 participants at risk
Study participants will be evaluated at the study center at least once per year.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Edema limbs
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Fever
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Flu like symptoms
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Pain
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Vascular disorders
Hypotension
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
Other adverse events
| Measure |
D-PACE/Induction
n=41 participants at risk
Initial chemotherapy will consist of 1 cycle of combination D-PACE chemotherapy and peripheral blood stem cell collection.
|
Post D-PACE/Pre-Transplant
n=41 participants at risk
Following D-PACE and Peripheral Blood Stem Cell (PBSC) collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days, but this may be omitted by the treating physician
|
Transplant
n=39 participants at risk
Transplant should preferably occur 6 weeks after the induction PACE continuous infusion has been completed, but can occur as early as 4 weeks and as late as 3 months if the participant fails to mobilize stem cells after the PACE administration
|
Post-transplant/Consolidation
n=38 participants at risk
Participants will receive dexamethasone 20 mg oral days 1-4 every 21 days and thalidomide 100 mg oral and daily in the interim between transplant and consolidation.
If administered, post-transplant consolidation therapy should begin 4-6 weeks after transplant, but should occur no later than 4 months after transplant. Consolidation will consist of one cycle of VDT-PACE.
|
Maintenance Therapy, Year 1
n=37 participants at risk
Maintenance will begin 4 weeks to 6 months after transplant, or between 6 weeks to 6 months after consolidation if administered. This is considered standard of care
|
Maintenance Therapy, Year 2
n=31 participants at risk
Maintenance will begin 4 weeks to 6 months after transplant, or between 6 weeks to 6 months after consolidation if administered. This is considered standard of care
|
Long Term Follow-up
n=24 participants at risk
Study participants will be evaluated at the study center at least once per year.
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.3%
3/41 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
24.4%
10/41 • Number of events 10 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
56.4%
22/39 • Number of events 22 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
7.9%
3/38 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
29.7%
11/37 • Number of events 20 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
29.0%
9/31 • Number of events 10 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Pain
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Edema limbs
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Edema trunk
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Fatigue
|
4.9%
2/41 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Flu like symptoms
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
10.3%
4/39 • Number of events 4 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
15.4%
6/39 • Number of events 6 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.4%
2/37 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Lung infection
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
10.3%
4/39 • Number of events 4 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
16.2%
6/37 • Number of events 6 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
9.7%
3/31 • Number of events 4 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
6.5%
2/31 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Infections and infestations
Wound infection
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Injury, poisoning and procedural complications
Wound complication
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
CD4 lymphocytes decreased
|
4.9%
2/41 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
17.1%
7/41 • Number of events 7 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
15.8%
6/38 • Number of events 6 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
62.2%
23/37 • Number of events 47 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
45.2%
14/31 • Number of events 19 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
GGT increased
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
INR increased
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
41/41 • Number of events 42 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
19.5%
8/41 • Number of events 8 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
92.3%
36/39 • Number of events 36 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
21.1%
8/38 • Number of events 10 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
73.0%
27/37 • Number of events 113 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
71.0%
22/31 • Number of events 85 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Neutrophil count decreased
|
80.5%
33/41 • Number of events 33 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
79.5%
31/39 • Number of events 31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.3%
2/38 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
8.1%
3/37 • Number of events 4 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
9.7%
3/31 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Pancreatic enzymes decreased
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Platelet count decreased
|
85.4%
35/41 • Number of events 35 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
97.4%
38/39 • Number of events 39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
7.9%
3/38 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
8.1%
3/37 • Number of events 5 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
16.1%
5/31 • Number of events 10 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
Weight loss
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
6.5%
2/31 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Investigations
White blood cell decreased
|
95.1%
39/41 • Number of events 40 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
97.4%
38/39 • Number of events 38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
7.9%
3/38 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
10.8%
4/37 • Number of events 25 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
12.9%
4/31 • Number of events 4 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.8%
4/41 • Number of events 4 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
10.3%
4/39 • Number of events 6 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
10.8%
4/37 • Number of events 24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
12.9%
4/31 • Number of events 8 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.8%
4/41 • Number of events 4 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
33.3%
13/39 • Number of events 13 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
15.4%
6/39 • Number of events 6 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.3%
2/38 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.4%
1/41 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Nervous system disorders
Akathisia
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
6.5%
2/31 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Psychiatric disorders
Anxiety
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Psychiatric disorders
Insomnia
|
4.9%
2/41 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
7.3%
3/41 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.4%
2/37 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Vascular disorders
Hypotension
|
4.9%
2/41 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
7.7%
3/39 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.4%
2/37 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
36.6%
15/41 • Number of events 15 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
4.9%
2/41 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
76.9%
30/39 • Number of events 33 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
8.1%
3/37 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
6.5%
2/31 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/38 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.3%
3/41 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
20.5%
8/39 • Number of events 8 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.3%
2/38 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
6.5%
2/31 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
8.1%
3/37 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
9.7%
3/31 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
12.5%
3/24 • Number of events 3 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Eye disorders
Corneal ulcer
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Eye disorders
Keratitis
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
17.9%
7/39 • Number of events 8 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.3%
2/38 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.4%
2/37 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
6.5%
2/31 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
10.3%
4/39 • Number of events 4 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
5.1%
2/39 • Number of events 2 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.6%
1/39 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
3.2%
1/31 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
|
General disorders
Fever
|
2.4%
1/41 • Number of events 1 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/41 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/39 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/38 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/37 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/31 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
0.00%
0/24 • Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place