Trial Outcomes & Findings for ARMS - Rapidly Generated Multivirus-Specific CTLs for Prophylaxis & Treatment of EBV, CMV, Adenovirus, HHV6 & BK Virus (NCT NCT01570283)
NCT ID: NCT01570283
Last Updated: 2019-05-30
Results Overview
DLT is defined as acute GvHD grades III-IV within 42 days of the last dose of CTLs, # of patients with Grade 3-5 infusion-related adverse events within 30 days of the last dose of CTLs, and # of patients with Grade 4-5 non-hematological adverse events within 30 days of the last dose of CTLs. GVHD grade III-IV scoring is based on the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) GVHD scoring stamp or equivalent. Grade 3-5 infusion-related adverse events and Grade 4-5 non-hematological adverse events are graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.X.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
42 days
Results posted on
2019-05-30
Participant Flow
Participant milestones
| Measure |
Multivirus-specific T Cells 5*10^6 mCTLs/m2 for Prophylaxis
Cohort 1 prophylaxis: Participants were administrated 5\*10\^6 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 5*10^6 mCTLs/m2 for Treatment
Cohort 1 treatment: Participants were administrated 5\*10\^6 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 1*10^7 mCTLs/m2 for Prophylaxis
Cohort 2 prophylaxis: Participants were administrated 1\*10\^7 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 1*10^7 mCTLs/m2 for Treatment
Cohort 2 treatment: Participants were administrated 1\*10\^7 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Prophylaxis
Cohort 3 prophylaxis: Participants were administrated 2\*10\^7 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Treatment
Cohort 3 treatment: Participants were administrated 2\*10\^7 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Dose Level 1
STARTED
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Cohort 1: Dose Level 1
COMPLETED
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Cohort 1: Dose Level 1
NOT COMPLETED
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Cohort 2: Dose Level 2
STARTED
|
0
|
0
|
2
|
2
|
0
|
0
|
|
Cohort 2: Dose Level 2
COMPLETED
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Cohort 2: Dose Level 2
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Cohort 3: Dose Level 3
STARTED
|
0
|
0
|
0
|
0
|
1
|
12
|
|
Cohort 3: Dose Level 3
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
10
|
|
Cohort 3: Dose Level 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Multivirus-specific T Cells 5*10^6 mCTLs/m2 for Prophylaxis
Cohort 1 prophylaxis: Participants were administrated 5\*10\^6 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 5*10^6 mCTLs/m2 for Treatment
Cohort 1 treatment: Participants were administrated 5\*10\^6 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 1*10^7 mCTLs/m2 for Prophylaxis
Cohort 2 prophylaxis: Participants were administrated 1\*10\^7 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 1*10^7 mCTLs/m2 for Treatment
Cohort 2 treatment: Participants were administrated 1\*10\^7 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Prophylaxis
Cohort 3 prophylaxis: Participants were administrated 2\*10\^7 mCTLs/m multivirus-specific T cells intravenously for prophylaxis of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 2*10^7 mCTLs/m2 for Treatment
Cohort 3 treatment: Participants were administrated 2\*10\^7 mCTLs/m multivirus-specific T cells intravenously for treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Dose Level 1
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Cohort 1: Dose Level 1
Received other hematopoietic cells
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Cohort 2: Dose Level 2
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Cohort 2: Dose Level 2
Received other hematopoietic cells
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Cohort 3: Dose Level 3
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Cohort 3: Dose Level 3
Received other hematopoietic cells
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
ARMS - Rapidly Generated Multivirus-Specific CTLs for Prophylaxis & Treatment of EBV, CMV, Adenovirus, HHV6 & BK Virus
Baseline characteristics by cohort
| Measure |
Multivirus-specific T Cells 5*10^6 mCTLs/m2
n=4 Participants
Cohort 1 (prophylaxis and treatment): Participants were administrated 5\*10\^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 1*10^7 mCTLs/m2
n=4 Participants
Cohort 2 (prophylaxis and treatment): Participants were administrated 1\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 2*10^7 mCTLs/m2
n=13 Participants
Cohort 3 (prophylaxis and treatment): Participants were administrated 2\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
12 years
n=7 Participants
|
9 years
n=5 Participants
|
9 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 42 daysPopulation: Data is reported for all participants who received multivirus-specific T cells. A participant is not evaluable for DLT if the participant was removed from the study before 42 days follow up due to a reason other than DLT.
DLT is defined as acute GvHD grades III-IV within 42 days of the last dose of CTLs, # of patients with Grade 3-5 infusion-related adverse events within 30 days of the last dose of CTLs, and # of patients with Grade 4-5 non-hematological adverse events within 30 days of the last dose of CTLs. GVHD grade III-IV scoring is based on the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) GVHD scoring stamp or equivalent. Grade 3-5 infusion-related adverse events and Grade 4-5 non-hematological adverse events are graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.X.
Outcome measures
| Measure |
Multivirus-specific T Cells 5*10^6 mCTLs/m2
n=4 Participants
Cohort 1 (prophylaxis and treatment): Participants were administrated 5\*10\^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 1*10^7 mCTLs/m2
n=4 Participants
Cohort 2 (prophylaxis and treatment): Participants were administrated 1\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 2*10^7 mCTLs/m2
n=13 Participants
Cohort 3 (prophylaxis and treatment): Participants were administrated 2\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
|---|---|---|---|
|
Number of Participants With a DLT
Not evaluable
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a DLT
DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a DLT
No DLT
|
3 Participants
|
4 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Data is reported for all participants who received multivirus-specific CTLs for treatment of EBV, CMV, adenovirus, HHV6 and BK virus.
Percentage of patients who have a response in anti-viral activity that is defined as a viral load reduction to the normal level for at least one of the five virus types
Outcome measures
| Measure |
Multivirus-specific T Cells 5*10^6 mCTLs/m2
n=3 Participants
Cohort 1 (prophylaxis and treatment): Participants were administrated 5\*10\^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 1*10^7 mCTLs/m2
n=2 Participants
Cohort 2 (prophylaxis and treatment): Participants were administrated 1\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 2*10^7 mCTLs/m2
n=12 Participants
Cohort 3 (prophylaxis and treatment): Participants were administrated 2\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
|---|---|---|---|
|
Percentage of Patients Who Have a Response in Anti-viral Activity
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
100 percentage of participants
Interval 15.8 to 100.0
|
83.3 percentage of participants
Interval 51.6 to 97.9
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data is reported for all participants who received multivirus-specific CTLs for treatment of EBV, CMV, adenovirus, HHV6 and BK virus.
Percentage change of viral load by PCR from baseline to follow-up. A positive number indicates a percentage decrease and a negative number indicates a percentage increase.
Outcome measures
| Measure |
Multivirus-specific T Cells 5*10^6 mCTLs/m2
n=3 Participants
Cohort 1 (prophylaxis and treatment): Participants were administrated 5\*10\^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 1*10^7 mCTLs/m2
n=2 Participants
Cohort 2 (prophylaxis and treatment): Participants were administrated 1\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 2*10^7 mCTLs/m2
n=12 Participants
Cohort 3 (prophylaxis and treatment): Participants were administrated 2\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
|---|---|---|---|
|
Percentage Change of Viral Load From Baseline to Follow-up
Adv
|
—
|
—
|
100 percentage change
Interval 100.0 to 100.0
|
|
Percentage Change of Viral Load From Baseline to Follow-up
BKV
|
100 percentage change
Interval 100.0 to 100.0
|
—
|
100 percentage change
Interval -27.6 to 100.0
|
|
Percentage Change of Viral Load From Baseline to Follow-up
CMV
|
99.2 percentage change
Interval 99.2 to 99.2
|
100 percentage change
Interval 100.0 to 100.0
|
100 percentage change
Interval -4.2 to 100.0
|
|
Percentage Change of Viral Load From Baseline to Follow-up
EBV
|
100 percentage change
Interval 100.0 to 100.0
|
100 percentage change
Interval 100.0 to 100.0
|
100 percentage change
Interval 100.0 to 100.0
|
|
Percentage Change of Viral Load From Baseline to Follow-up
HHV6
|
—
|
100 percentage change
Interval 100.0 to 100.0
|
-7.0 percentage change
Interval -14.0 to 0.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data is reported for all participants who received multivirus-specific CTLs for treatment of EBV, CMV, adenovirus, HHV6 and BK virus.
Median peak frequency of specific T cells as measured by Elispot to assess reconstitution of antiviral immunity.
Outcome measures
| Measure |
Multivirus-specific T Cells 5*10^6 mCTLs/m2
n=3 Participants
Cohort 1 (prophylaxis and treatment): Participants were administrated 5\*10\^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 1*10^7 mCTLs/m2
n=2 Participants
Cohort 2 (prophylaxis and treatment): Participants were administrated 1\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 2*10^7 mCTLs/m2
n=12 Participants
Cohort 3 (prophylaxis and treatment): Participants were administrated 2\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
|---|---|---|---|
|
Median Peak Frequency of Specific T Cells Post-infusion
ADV
|
—
|
—
|
224.0 spot forming cells/5 * 10^5 input cells
Interval 6.0 to 225.0
|
|
Median Peak Frequency of Specific T Cells Post-infusion
BKV
|
42.3 spot forming cells/5 * 10^5 input cells
Interval 10.5 to 74.0
|
—
|
271.3 spot forming cells/5 * 10^5 input cells
Interval 5.0 to 932.0
|
|
Median Peak Frequency of Specific T Cells Post-infusion
CMV
|
28.5 spot forming cells/5 * 10^5 input cells
Interval 28.5 to 28.5
|
1023.0 spot forming cells/5 * 10^5 input cells
Interval 1023.0 to 1023.0
|
884.5 spot forming cells/5 * 10^5 input cells
Interval 386.0 to 2656.0
|
|
Median Peak Frequency of Specific T Cells Post-infusion
EBV
|
497.0 spot forming cells/5 * 10^5 input cells
Interval 497.0 to 497.0
|
40.0 spot forming cells/5 * 10^5 input cells
Interval 40.0 to 40.0
|
224.0 spot forming cells/5 * 10^5 input cells
Interval 224.0 to 224.0
|
|
Median Peak Frequency of Specific T Cells Post-infusion
HHV6
|
—
|
175.0 spot forming cells/5 * 10^5 input cells
Interval 175.0 to 175.0
|
24.8 spot forming cells/5 * 10^5 input cells
Interval 3.0 to 46.5
|
Adverse Events
Multivirus-specific T Cells 5*10^6 mCTLs/m2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Multivirus-specific T Cells 1*10^7 mCTLs/m2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Multivirus-specific T Cells 2*10^7 mCTLs/m2
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Multivirus-specific T Cells 5*10^6 mCTLs/m2
n=4 participants at risk
Cohort 1 (prophylaxis and treatment): Participants were administrated 5\*10\^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 1*10^7 mCTLs/m2
n=4 participants at risk
Cohort 2 (prophylaxis and treatment): Participants were administrated 1\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 2*10^7 mCTLs/m2
n=13 participants at risk
Cohort 3 (prophylaxis and treatment): Participants were administrated 2\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Chills
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Fever
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Infections and infestations - Other, specify: RSV
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Infections and infestations - Other, specify: rhinovirus
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Urethral infection
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: dysuria
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: Rhinorrhea
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: lung inflitrates
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
Other adverse events
| Measure |
Multivirus-specific T Cells 5*10^6 mCTLs/m2
n=4 participants at risk
Cohort 1 (prophylaxis and treatment): Participants were administrated 5\*10\^6 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 1*10^7 mCTLs/m2
n=4 participants at risk
Cohort 2 (prophylaxis and treatment): Participants were administrated 1\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
Multivirus-specific T Cells 2*10^7 mCTLs/m2
n=13 participants at risk
Cohort 3 (prophylaxis and treatment): Participants were administrated 2\*10\^7 mCTLs/m multivirus-specific T cells intravenously for the prophylaxis and treatment of EBV, CMV, Adenovirus, HHV6 and BK virus infections post allogeneic stem cell transplant.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
4/4 • Number of events 25 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
75.0%
3/4 • Number of events 12 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
76.9%
10/13 • Number of events 38 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
15.4%
2/13 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Eye disorders
Watering eyes
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
15.4%
2/13 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 10 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
50.0%
2/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
30.8%
4/13 • Number of events 7 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Intercurrent gastroenteritis
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
38.5%
5/13 • Number of events 6 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Rectal pain
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
53.8%
7/13 • Number of events 10 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Chills
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Edema face
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Edema limbs
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
53.8%
7/13 • Number of events 8 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Fever
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
15.4%
2/13 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
15.4%
2/13 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
General disorders and administration site conditions - Other, specify: PICC line pain
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
General disorders and administration site conditions - Other, specify: flank pain
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
General disorders and administration site conditions - Other, specify: pain- knees
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
General disorders and administration site conditions - Other, specify: pain- legs
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Irritability
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Localized edema
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
15.4%
2/13 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Eye infection
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Infections and infestations - Other, specify: Rhinovirus
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Infections and infestations - Other, specify: clostridium difficile
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Infections and infestations - Other, specify: human herpes virus 7
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Infections and infestations - Other, specify: oral thrush
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Infections and infestations - Other, specify: oropharyngeal candidiasis
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
15.4%
2/13 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Infections and infestations - Other, specify: rhinovirus
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
50.0%
2/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Otitis externa
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Otitis media
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
15.4%
2/13 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
50.0%
2/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
30.8%
4/13 • Number of events 8 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Investigations
Creatinine increased
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 7 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Investigations
Hemoglobin increased
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
4/4 • Number of events 12 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
84.6%
11/13 • Number of events 36 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Investigations
Neutrophil count decreased
|
50.0%
2/4 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
69.2%
9/13 • Number of events 45 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Investigations
Platelet count decreased
|
75.0%
3/4 • Number of events 20 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
61.5%
8/13 • Number of events 56 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Investigations
White blood cell decreased
|
100.0%
4/4 • Number of events 11 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
50.0%
2/4 • Number of events 9 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
76.9%
10/13 • Number of events 39 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
38.5%
5/13 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 7 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
75.0%
3/4 • Number of events 15 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
50.0%
2/4 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
61.5%
8/13 • Number of events 27 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
50.0%
2/4 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
15.4%
2/13 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 7 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 6 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Number of events 9 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
30.8%
4/13 • Number of events 15 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.0%
1/4 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
38.5%
5/13 • Number of events 8 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
2/4 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
38.5%
5/13 • Number of events 7 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
1/4 • Number of events 7 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: delayed speech
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Nervous system disorders
Nervous system disorders - Other, specify: right hand weakness
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Renal and urinary disorders
Hematuria
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
75.0%
3/4 • Number of events 4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 6 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: dysuria
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
15.4%
2/13 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
50.0%
2/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
30.8%
4/13 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: rhinorrhea
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
25.0%
1/4 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 6 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
23.1%
3/13 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: diaper rash
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: lacy rash
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: rosacea
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: skin irritation
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
25.0%
1/4 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: umbilical wound
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
30.8%
4/13 • Number of events 4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
7.7%
1/13 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/4 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
0.00%
0/13 • Data on adverse experiences/toxicities regardless of seriousness must be collected for documentation purposes only for 30 days after the last dosing of the study drug/biologic with the exception of acute GVHD which will be followed for 6 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place