Trial Outcomes & Findings for A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT) (NCT NCT01877655)
NCT ID: NCT01877655
Last Updated: 2024-10-24
Results Overview
This was the composite of all-cause mortality and adjudicated CMV EOD through 1 year posttransplant, The CMV EOD was assessed by the independent and blinded adjudication committee, which counted events that were observed up to day 380 from transplantation. Deaths that occurred up to day 365 from transplant were also counted.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
514 participants
Primary outcome timeframe
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Results posted on
2024-10-24
Participant Flow
A total of 514 participants were enrolled across 11 countries. At least 30% of enrolled participants had cytomegalovirus (CMV) seronegative donor and underwent allogeneic hematopoietic cell transplant (HCT). After the primary study period (day 365) participants were monitored for 5.5 years post-transplant for long-term safety. After the primary period completion, 326 participants entered the long-term follow-up period.
Screening assessment occurred from 30 to 5 days before transplant. Participants who met the inclusion and none of the exclusion criteria were randomly assigned in a 1:1 ratio to receive either ASP0113 or placebo. The randomization to treatment was stratified by donor-recipient relatedness and by donor CMV serostatus.
Participant milestones
| Measure |
Placebo
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
ASP0113 5mg
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
|---|---|---|
|
Overall Study
STARTED
|
263
|
251
|
|
Overall Study
Received Treatment
|
255
|
246
|
|
Overall Study
COMPLETED
|
165
|
154
|
|
Overall Study
NOT COMPLETED
|
98
|
97
|
Reasons for withdrawal
| Measure |
Placebo
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
ASP0113 5mg
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
|---|---|---|
|
Overall Study
Death
|
57
|
52
|
|
Overall Study
Withdrawal by Subject
|
18
|
26
|
|
Overall Study
Physician Decision
|
11
|
10
|
|
Overall Study
Miscellaneous
|
4
|
4
|
|
Overall Study
Randomized but Never Received Drug
|
8
|
5
|
Baseline Characteristics
The analysis population was the all randomized.
Baseline characteristics by cohort
| Measure |
Placebo
n=263 Participants
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
ASP0113
n=251 Participants
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
Total
n=514 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 Year
STANDARD_DEVIATION 13.15 • n=99 Participants • The analysis population was the all randomized.
|
51.8 Year
STANDARD_DEVIATION 12.41 • n=107 Participants • The analysis population was the all randomized.
|
51.9 Year
STANDARD_DEVIATION 12.78 • n=206 Participants • The analysis population was the all randomized.
|
|
Sex: Female, Male
Female
|
105 Participants
n=99 Participants • The analysis population was the all randomized.
|
110 Participants
n=107 Participants • The analysis population was the all randomized.
|
215 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Sex: Female, Male
Male
|
158 Participants
n=99 Participants • The analysis population was the all randomized.
|
141 Participants
n=107 Participants • The analysis population was the all randomized.
|
299 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants • The analysis population was the all randomized.
|
19 Participants
n=107 Participants • The analysis population was the all randomized.
|
30 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
252 Participants
n=99 Participants • The analysis population was the all randomized.
|
232 Participants
n=107 Participants • The analysis population was the all randomized.
|
484 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • The analysis population was the all randomized.
|
0 Participants
n=107 Participants • The analysis population was the all randomized.
|
0 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • The analysis population was the all randomized.
|
0 Participants
n=107 Participants • The analysis population was the all randomized.
|
0 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Race (NIH/OMB)
Asian
|
47 Participants
n=99 Participants • The analysis population was the all randomized.
|
50 Participants
n=107 Participants • The analysis population was the all randomized.
|
97 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • The analysis population was the all randomized.
|
0 Participants
n=107 Participants • The analysis population was the all randomized.
|
0 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants • The analysis population was the all randomized.
|
7 Participants
n=107 Participants • The analysis population was the all randomized.
|
13 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Race (NIH/OMB)
White
|
189 Participants
n=99 Participants • The analysis population was the all randomized.
|
177 Participants
n=107 Participants • The analysis population was the all randomized.
|
366 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • The analysis population was the all randomized.
|
0 Participants
n=107 Participants • The analysis population was the all randomized.
|
0 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=99 Participants • The analysis population was the all randomized.
|
17 Participants
n=107 Participants • The analysis population was the all randomized.
|
38 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Strata
Related Seropositive Donor
|
65 Participants
n=99 Participants • The analysis population was the all randomized.
|
73 Participants
n=107 Participants • The analysis population was the all randomized.
|
138 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Strata
Related Seronegative Donor
|
30 Participants
n=99 Participants • The analysis population was the all randomized.
|
26 Participants
n=107 Participants • The analysis population was the all randomized.
|
56 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Strata
Non-related Seropositive Donor
|
96 Participants
n=99 Participants • The analysis population was the all randomized.
|
73 Participants
n=107 Participants • The analysis population was the all randomized.
|
169 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Strata
Non-related Seronegative Donor
|
72 Participants
n=99 Participants • The analysis population was the all randomized.
|
79 Participants
n=107 Participants • The analysis population was the all randomized.
|
151 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Primary Diagnosis
Acute Myeloid Leukemia (AML)
|
126 Participants
n=99 Participants • The analysis population was the all randomized.
|
97 Participants
n=107 Participants • The analysis population was the all randomized.
|
223 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Primary Diagnosis
Acute Lymphoblastic Leukemia (ALL)
|
34 Participants
n=99 Participants • The analysis population was the all randomized.
|
34 Participants
n=107 Participants • The analysis population was the all randomized.
|
68 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Primary Diagnosis
Acute Undifferentiated Leukemia (AUL)
|
1 Participants
n=99 Participants • The analysis population was the all randomized.
|
2 Participants
n=107 Participants • The analysis population was the all randomized.
|
3 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Primary Diagnosis
Acute Biphenotypic Leukemia (ABL)
|
2 Participants
n=99 Participants • The analysis population was the all randomized.
|
2 Participants
n=107 Participants • The analysis population was the all randomized.
|
4 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Primary Diagnosis
Chronic Myelogenous Leukemia (CML)
|
6 Participants
n=99 Participants • The analysis population was the all randomized.
|
12 Participants
n=107 Participants • The analysis population was the all randomized.
|
18 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Primary Diagnosis
Chronic Lymphocytic Leukemia (CLL)
|
7 Participants
n=99 Participants • The analysis population was the all randomized.
|
10 Participants
n=107 Participants • The analysis population was the all randomized.
|
17 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Primary Diagnosis
Myelodysplastic Syndrome
|
46 Participants
n=99 Participants • The analysis population was the all randomized.
|
51 Participants
n=107 Participants • The analysis population was the all randomized.
|
97 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Primary Diagnosis
Primary or Secondary Myelofibrosis
|
8 Participants
n=99 Participants • The analysis population was the all randomized.
|
11 Participants
n=107 Participants • The analysis population was the all randomized.
|
19 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Primary Diagnosis
Lymphoma
|
33 Participants
n=99 Participants • The analysis population was the all randomized.
|
31 Participants
n=107 Participants • The analysis population was the all randomized.
|
64 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Primary Diagnosis
Missing
|
0 Participants
n=99 Participants • The analysis population was the all randomized.
|
1 Participants
n=107 Participants • The analysis population was the all randomized.
|
1 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Conditioning Regimen
Myeloablative
|
122 Participants
n=99 Participants • The analysis population was the all randomized.
|
120 Participants
n=107 Participants • The analysis population was the all randomized.
|
242 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Conditioning Regimen
Non-Myeloablative
|
131 Participants
n=99 Participants • The analysis population was the all randomized.
|
124 Participants
n=107 Participants • The analysis population was the all randomized.
|
255 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Conditioning Regimen
Missing
|
10 Participants
n=99 Participants • The analysis population was the all randomized.
|
7 Participants
n=107 Participants • The analysis population was the all randomized.
|
17 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Antithymocyte Globulin (ATG) Use
Yes
|
45 Participants
n=99 Participants • The analysis population was the all randomized.
|
43 Participants
n=107 Participants • The analysis population was the all randomized.
|
88 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Antithymocyte Globulin (ATG) Use
No
|
218 Participants
n=99 Participants • The analysis population was the all randomized.
|
208 Participants
n=107 Participants • The analysis population was the all randomized.
|
426 Participants
n=206 Participants • The analysis population was the all randomized.
|
|
Height
|
170.6 Centimeteres
STANDARD_DEVIATION 9.91 • n=99 Participants • The analysis population was the all randomized.
|
169.7 Centimeteres
STANDARD_DEVIATION 9.88 • n=107 Participants • The analysis population was the all randomized.
|
170.2 Centimeteres
STANDARD_DEVIATION 9.90 • n=206 Participants • The analysis population was the all randomized.
|
|
Body Mass Index (BMI)
|
27.0 kg/m^2
STANDARD_DEVIATION 5.02 • n=99 Participants • The analysis population was the all randomized.
|
26.0 kg/m^2
STANDARD_DEVIATION 5.05 • n=107 Participants • The analysis population was the all randomized.
|
26.5 kg/m^2
STANDARD_DEVIATION 5.06 • n=206 Participants • The analysis population was the all randomized.
|
PRIMARY outcome
Timeframe: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)Population: The analysis population was the full analysis set (FAS), which consisted of all randomized participants who received at least one dose of randomized study drug.
This was the composite of all-cause mortality and adjudicated CMV EOD through 1 year posttransplant, The CMV EOD was assessed by the independent and blinded adjudication committee, which counted events that were observed up to day 380 from transplantation. Deaths that occurred up to day 365 from transplant were also counted.
Outcome measures
| Measure |
Placebo
n=255 Participants
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
ASP0113
n=246 Participants
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
|---|---|---|
|
Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant
Participants With Composite Endpoint
|
30.20 Percentage of Participants
|
35.37 Percentage of Participants
|
|
Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant
All-Cause Mortality
|
28.24 Percentage of Participants
|
31.71 Percentage of Participants
|
|
Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant
Adjudicated CMV EOD
|
3.53 Percentage of Participants
|
6.10 Percentage of Participants
|
SECONDARY outcome
Timeframe: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)Population: The analysis population was the FAS.
Protocol-defined CMV viremia was defined as a CMV plasma viral load ≥1000 IU/mL as assessed by the central laboratory. Rate was based on cumulative incidence function estimated at 1 year. The central laboratory had the lower limit of quantification \[LLOQ\] for CMV viral load assessment, so when the viral load was below the LLOQ the actual viral load reading was not possible and was denoted as ≤LLOQ. If participant had any CMV viral load assessments greater than the LLOQ it was classified as viremic.
Outcome measures
| Measure |
Placebo
n=255 Participants
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
ASP0113
n=246 Participants
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
|---|---|---|
|
Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant
|
58.6 Percentage of Participants
Interval 52.0 to 64.6
|
56.7 Percentage of Participants
Interval 50.1 to 62.8
|
SECONDARY outcome
Timeframe: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)Population: The analysis population was the FAS.
The CMV-specific AVT use was adjudicated by the independent and blinded committee. When the CMV-specific AVT was initiated, a central CMV viral load was obtained weekly until it was discontinued. Participants without any CMV-specific AVT events were censored on the last study evaluation.
Outcome measures
| Measure |
Placebo
n=255 Participants
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
ASP0113
n=246 Participants
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
|---|---|---|
|
Percentage of Participants With Adjudicated CMV-Specific Antiviral Therapy (AVT) Through 1 Year Posttransplant
|
53.2 Percentage of Participants
Interval 46.8 to 59.1
|
54.6 Percentage of Participants
Interval 48.1 to 60.6
|
SECONDARY outcome
Timeframe: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)Population: The analysis population was the FAS.
Protocol-defined CMV viremia was as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.
Outcome measures
| Measure |
Placebo
n=255 Participants
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
ASP0113
n=246 Participants
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
|---|---|---|
|
Percentage of Participants With a Composite Endpoint of Protocol-defined CMV Viremia and Adjudicated CMV-Specific AVT Use
|
60.78 Percentage of Participants
|
60.98 Percentage of Participants
|
SECONDARY outcome
Timeframe: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)Population: The analysis population was the FAS.
Rate was based on cumulative incidence function estimate at 1 year. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD were determined by the adjudication committee. This endpoint was a composite endpoint based on the independent adjudication committee assessments of CMV-specific AVT and CMV EOD.
Outcome measures
| Measure |
Placebo
n=255 Participants
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
ASP0113
n=246 Participants
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
|---|---|---|
|
Percentage of Participants With First Occurrence of Adjudicated CMV-specific AVT or Adjudicated Diagnosis of CMV EOD After Study Drug First Injection Through 1 Year Posttransplant
|
54.4 Percentage of Participants
Interval 48.0 to 60.3
|
55.4 Percentage of Participants
Interval 48.9 to 61.5
|
SECONDARY outcome
Timeframe: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)Population: The analysis population was the FAS.
All-cause mortality through 1-year post-transplantation summary included all deaths and unknown survival status. For the known deaths, the adjudication committee assessed results and summarized them according to the following category: Mortality due to the participant's primary disease, and mortality due to causes unrelated to the participant's primary disease. Participants with unknown survival status at 1 year were considered dead for this analysis.
Outcome measures
| Measure |
Placebo
n=255 Participants
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
ASP0113
n=246 Participants
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
|---|---|---|
|
All-Cause Mortality at 1 Year Posttransplant
|
28.24 Percentage of Participants
|
31.71 Percentage of Participants
|
Adverse Events
Placebo
Serious events: 221 serious events
Other events: 254 other events
Deaths: 100 deaths
ASP0113 5mg
Serious events: 221 serious events
Other events: 244 other events
Deaths: 105 deaths
Serious adverse events
| Measure |
Placebo
n=255 participants at risk
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
ASP0113 5mg
n=246 participants at risk
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
1.2%
3/255 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Aplasia pure red cell
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
11/255 • Number of events 13 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.5%
11/246 • Number of events 14 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.0%
5/255 • Number of events 6 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
2.0%
5/246 • Number of events 6 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Angina pectoris
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
3/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.6%
4/246 • Number of events 5 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Cardiac failure
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Cardiogenic shock
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Pericardial effusion
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Pericarditis
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Ear and labyrinth disorders
Aural polyp
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Eye disorders
Mydriasis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.78%
2/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Anal fissure
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Ascites
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
11/255 • Number of events 11 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.1%
10/246 • Number of events 13 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Enteritis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Gastrooesophagitis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Megacolon
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
8/255 • Number of events 8 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.1%
10/246 • Number of events 10 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Proctalgia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
7/255 • Number of events 7 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.5%
11/246 • Number of events 12 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Asthenia
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.6%
4/246 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Chest pain
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Chills
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Drug resistance
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Fatigue
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
General physical health deterioration
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Malaise
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Mucosal inflammation
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Multi-organ failure
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
2.4%
6/246 • Number of events 6 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Non-cardiac chest pain
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Oedema due to cardiac disease
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Pyrexia
|
9.0%
23/255 • Number of events 29 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
10.6%
26/246 • Number of events 27 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Serositis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Sudden death
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Hepatobiliary disorders
Hepatic vein occlusion
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
1.6%
4/255 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
2.0%
5/246 • Number of events 5 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Acute graft versus host disease
|
3.5%
9/255 • Number of events 10 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
2.8%
7/246 • Number of events 7 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
29.8%
76/255 • Number of events 120 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
30.9%
76/246 • Number of events 123 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Acute graft versus host disease in liver
|
9.4%
24/255 • Number of events 30 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
7.3%
18/246 • Number of events 23 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Acute graft versus host disease in skin
|
47.8%
122/255 • Number of events 171 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
48.0%
118/246 • Number of events 165 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Alloimmunisation
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Chronic graft versus host disease
|
1.6%
4/255 • Number of events 5 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Chronic graft versus host disease in intestine
|
2.4%
6/255 • Number of events 7 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Chronic graft versus host disease in liver
|
2.7%
7/255 • Number of events 7 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Chronic graft versus host disease in skin
|
2.0%
5/255 • Number of events 5 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Abdominal abscess
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Abscess intestinal
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Anorectal cellulitis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Aspergillosis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Atypical pneumonia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
BK virus infection
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Bacteraemia
|
1.6%
4/255 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.6%
4/246 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Bacterial sepsis
|
1.2%
3/255 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Bronchitis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
1.2%
3/255 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.6%
4/246 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Cellulitis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Cerebral aspergillosis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Citrobacter sepsis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Clostridium difficile colitis
|
2.0%
5/255 • Number of events 5 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Clostridium difficile infection
|
1.6%
4/255 • Number of events 5 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Cystitis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Cytomegalovirus gastritis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Cytomegalovirus gastroenteritis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Cytomegalovirus infection
|
2.4%
6/255 • Number of events 6 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.1%
10/246 • Number of events 10 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
3.5%
9/255 • Number of events 11 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.5%
11/246 • Number of events 13 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Device related infection
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Device related sepsis
|
1.2%
3/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Diverticulitis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Encephalitis cytomegalovirus
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Encephalitis herpes
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.78%
2/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Enterococcal sepsis
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Epstein-Barr viraemia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Escherichia sepsis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Gangrene
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Gastroenteritis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Hepatic candidiasis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Herpes zoster
|
2.0%
5/255 • Number of events 7 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.6%
4/246 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Human polyomavirus infection
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Infection
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Influenza
|
1.2%
3/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Klebsiella sepsis
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Lobar pneumonia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Localised infection
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Lung infection
|
0.78%
2/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.6%
4/246 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Neutropenic sepsis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Oral candidiasis
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Peritonitis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia
|
5.9%
15/255 • Number of events 18 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
7.7%
19/246 • Number of events 20 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia adenoviral
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia escherichia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia fungal
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia herpes viral
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia influenzal
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia legionella
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia viral
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
3/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.6%
4/246 • Number of events 5 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Sepsis
|
7.8%
20/255 • Number of events 23 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
5.7%
14/246 • Number of events 14 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Septic shock
|
3.5%
9/255 • Number of events 10 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.1%
10/246 • Number of events 10 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Sinusitis
|
1.2%
3/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Sinusitis fungal
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Skin infection
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.6%
4/255 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
2.0%
5/246 • Number of events 6 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Subcutaneous abscess
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Systemic mycosis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.6%
4/246 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Viral haemorrhagic cystitis
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Viral infection
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Blood stem cell transplant failure
|
1.6%
4/255 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Drug dose omission
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Transfusion microchimerism
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
1.2%
3/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Computerised tomogram thorax abnormal
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Immunosuppressant drug level increased
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Liver function test abnormal
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Platelet count decreased
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Transaminases increased
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Weight decreased
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
4/255 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.6%
4/246 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.39%
1/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
2.4%
6/255 • Number of events 8 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
2.0%
5/246 • Number of events 5 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
2.4%
6/246 • Number of events 6 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
7.1%
18/255 • Number of events 21 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.9%
17/246 • Number of events 22 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adult T-cell lymphoma/leukaemia recurrent
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia recurrent
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemic infiltration brain
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Monoclonal gammopathy
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides recurrent
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.2%
3/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
2.0%
5/246 • Number of events 5 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma recurrent
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral T-cell lymphoma unspecified recurrent
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
1.2%
3/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma recurrent
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell type acute leukaemia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Acute polyneuropathy
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Coma
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Convulsion
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Dizziness
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Encephalopathy
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Facial paresis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Headache
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Memory impairment
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Migraine
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Neurological decompensation
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Paraplegia
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Psychiatric disorders
Confusional state
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Psychiatric disorders
Delirium
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Psychiatric disorders
Mania
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Psychiatric disorders
Mental disorder
|
0.39%
1/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Psychiatric disorders
Mental status changes
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Renal failure
|
2.0%
5/255 • Number of events 6 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Renal failure acute
|
16.1%
41/255 • Number of events 46 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
11.4%
28/246 • Number of events 38 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Renal impairment
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.4%
6/255 • Number of events 6 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.6%
4/255 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
4/255 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.39%
1/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
1.2%
3/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
7/255 • Number of events 7 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.3%
11/255 • Number of events 13 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
3.3%
8/246 • Number of events 8 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Surgical and medical procedures
Appendicectomy
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Surgical and medical procedures
Central venous catheter removal
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Surgical and medical procedures
Colectomy
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Surgical and medical procedures
Donor leukocyte infusion
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Surgical and medical procedures
Drug therapy
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Surgical and medical procedures
Stem cell transplant
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.78%
2/255 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Vascular disorders
Haematoma
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Vascular disorders
Hypotension
|
1.2%
3/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.81%
2/246 • Number of events 2 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Vascular disorders
Microangiopathy
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/255 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Vascular disorders
Thrombophlebitis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Vascular disorders
Venoocclusive disease
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.41%
1/246 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Vascular disorders
Venous thrombosis
|
0.39%
1/255 • Number of events 1 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
0.00%
0/246 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
Other adverse events
| Measure |
Placebo
n=255 participants at risk
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
ASP0113 5mg
n=246 participants at risk
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
29.4%
75/255 • Number of events 160 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
26.8%
66/246 • Number of events 146 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
36.1%
92/255 • Number of events 98 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
37.0%
91/246 • Number of events 101 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.0%
23/255 • Number of events 56 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.1%
20/246 • Number of events 51 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.5%
65/255 • Number of events 98 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
26.4%
65/246 • Number of events 99 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
7.1%
18/255 • Number of events 19 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.5%
21/246 • Number of events 21 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.8%
48/255 • Number of events 111 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
19.9%
49/246 • Number of events 131 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Cardiac disorders
Tachycardia
|
8.6%
22/255 • Number of events 24 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.9%
22/246 • Number of events 28 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Eye disorders
Conjunctivitis
|
6.7%
17/255 • Number of events 18 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.9%
12/246 • Number of events 12 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Eye disorders
Dry eye
|
14.5%
37/255 • Number of events 39 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
17.1%
42/246 • Number of events 45 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.1%
8/255 • Number of events 11 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
5.3%
13/246 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.6%
22/255 • Number of events 22 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.1%
15/246 • Number of events 18 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.5%
60/255 • Number of events 83 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
25.2%
62/246 • Number of events 84 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.9%
33/255 • Number of events 37 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
10.6%
26/246 • Number of events 32 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
40.4%
103/255 • Number of events 128 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
36.6%
90/246 • Number of events 119 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
65.5%
167/255 • Number of events 244 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
67.5%
166/246 • Number of events 242 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Dry mouth
|
9.8%
25/255 • Number of events 31 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
12.2%
30/246 • Number of events 35 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
25/255 • Number of events 27 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
12.6%
31/246 • Number of events 35 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Gastritis
|
7.5%
19/255 • Number of events 19 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
7.7%
19/246 • Number of events 20 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.3%
16/255 • Number of events 17 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
9.8%
24/246 • Number of events 25 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.0%
23/255 • Number of events 26 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
11.0%
27/246 • Number of events 28 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
69.4%
177/255 • Number of events 261 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
72.4%
178/246 • Number of events 273 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Oral pain
|
6.3%
16/255 • Number of events 17 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
7.7%
19/246 • Number of events 20 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Proctalgia
|
7.8%
20/255 • Number of events 20 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.1%
20/246 • Number of events 23 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Stomatitis
|
27.1%
69/255 • Number of events 96 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
32.1%
79/246 • Number of events 105 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
47.8%
122/255 • Number of events 178 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
50.8%
125/246 • Number of events 195 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Asthenia
|
13.3%
34/255 • Number of events 43 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
12.2%
30/246 • Number of events 39 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Catheter site pain
|
8.2%
21/255 • Number of events 23 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.9%
22/246 • Number of events 29 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Chills
|
17.3%
44/255 • Number of events 59 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
14.6%
36/246 • Number of events 46 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Fatigue
|
27.1%
69/255 • Number of events 80 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
23.6%
58/246 • Number of events 65 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Injection site erythema
|
2.0%
5/255 • Number of events 5 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
19.9%
49/246 • Number of events 72 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Injection site induration
|
1.2%
3/255 • Number of events 3 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
15.4%
38/246 • Number of events 57 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Injection site pain
|
18.4%
47/255 • Number of events 83 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
78.5%
193/246 • Number of events 1053 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Injection site swelling
|
1.6%
4/255 • Number of events 4 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
9.8%
24/246 • Number of events 36 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Malaise
|
3.9%
10/255 • Number of events 11 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.1%
15/246 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Mucosal inflammation
|
39.6%
101/255 • Number of events 147 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
30.5%
75/246 • Number of events 94 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Oedema
|
8.2%
21/255 • Number of events 24 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
14.2%
35/246 • Number of events 39 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Oedema peripheral
|
27.1%
69/255 • Number of events 95 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
26.8%
66/246 • Number of events 88 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Pain
|
12.5%
32/255 • Number of events 34 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
11.0%
27/246 • Number of events 34 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
General disorders
Pyrexia
|
50.2%
128/255 • Number of events 195 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
50.0%
123/246 • Number of events 180 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.3%
16/255 • Number of events 23 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
5.3%
13/246 • Number of events 17 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Chronic graft versus host disease
|
23.5%
60/255 • Number of events 109 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
25.2%
62/246 • Number of events 110 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Chronic graft versus host disease in intestine
|
8.2%
21/255 • Number of events 28 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.1%
20/246 • Number of events 22 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Chronic graft versus host disease in liver
|
13.7%
35/255 • Number of events 45 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
12.2%
30/246 • Number of events 43 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Chronic graft versus host disease in skin
|
18.0%
46/255 • Number of events 51 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
15.0%
37/246 • Number of events 40 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Engraftment syndrome
|
3.5%
9/255 • Number of events 9 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
5.3%
13/246 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
7.5%
19/255 • Number of events 20 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.1%
20/246 • Number of events 20 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
BK virus infection
|
5.1%
13/255 • Number of events 13 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
5.3%
13/246 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Clostridium difficile infection
|
6.3%
16/255 • Number of events 16 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.9%
17/246 • Number of events 18 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Cytomegalovirus infection
|
20.0%
51/255 • Number of events 64 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
18.3%
45/246 • Number of events 68 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
37.6%
96/255 • Number of events 141 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
35.4%
87/246 • Number of events 132 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Device related infection
|
6.3%
16/255 • Number of events 16 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.5%
16/246 • Number of events 18 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Epstein-Barr virus infection
|
5.1%
13/255 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.1%
15/246 • Number of events 16 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Escherichia urinary tract infection
|
4.3%
11/255 • Number of events 11 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
5.3%
13/246 • Number of events 20 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Folliculitis
|
5.5%
14/255 • Number of events 18 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
3.3%
8/246 • Number of events 8 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
12/255 • Number of events 14 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.1%
15/246 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Oral candidiasis
|
10.6%
27/255 • Number of events 31 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.9%
17/246 • Number of events 18 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Oral herpes
|
6.7%
17/255 • Number of events 18 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
3.3%
8/246 • Number of events 13 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Pneumonia
|
5.1%
13/255 • Number of events 13 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
5.3%
13/246 • Number of events 13 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
6.7%
17/255 • Number of events 20 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.1%
20/246 • Number of events 23 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.6%
27/255 • Number of events 36 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.9%
22/246 • Number of events 24 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
3.9%
10/255 • Number of events 12 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.1%
15/246 • Number of events 17 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Alanine aminotransferase increased
|
12.2%
31/255 • Number of events 47 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
13.4%
33/246 • Number of events 66 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
30/255 • Number of events 45 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
12.2%
30/246 • Number of events 49 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.7%
17/255 • Number of events 24 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
7.3%
18/246 • Number of events 23 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Blood bilirubin increased
|
9.0%
23/255 • Number of events 48 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.5%
21/246 • Number of events 43 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Blood creatinine increased
|
11.4%
29/255 • Number of events 42 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.9%
22/246 • Number of events 27 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.1%
13/255 • Number of events 24 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.1%
15/246 • Number of events 26 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Neutrophil count decreased
|
12.9%
33/255 • Number of events 70 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
11.4%
28/246 • Number of events 62 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Platelet count decreased
|
14.5%
37/255 • Number of events 83 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
11.4%
28/246 • Number of events 49 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Transaminases increased
|
3.9%
10/255 • Number of events 11 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
7.3%
18/246 • Number of events 19 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
Weight decreased
|
5.9%
15/255 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.9%
12/246 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Investigations
White blood cell count decreased
|
9.0%
23/255 • Number of events 65 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
9.8%
24/246 • Number of events 45 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.7%
91/255 • Number of events 109 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
29.3%
72/246 • Number of events 89 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
13/255 • Number of events 16 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
5.3%
13/246 • Number of events 31 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.1%
8/255 • Number of events 8 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.9%
17/246 • Number of events 19 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Fluid overload
|
5.5%
14/255 • Number of events 14 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.5%
11/246 • Number of events 16 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.9%
66/255 • Number of events 90 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
22.0%
54/246 • Number of events 81 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.0%
23/255 • Number of events 40 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
12.2%
30/246 • Number of events 43 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.9%
10/255 • Number of events 14 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.1%
15/246 • Number of events 17 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.8%
30/255 • Number of events 43 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
9.8%
24/246 • Number of events 53 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.5%
37/255 • Number of events 58 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
11.4%
28/246 • Number of events 51 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
32.5%
83/255 • Number of events 120 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
37.4%
92/246 • Number of events 140 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
44.3%
113/255 • Number of events 157 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
45.9%
113/246 • Number of events 168 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.8%
25/255 • Number of events 42 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
10.6%
26/246 • Number of events 32 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.6%
27/255 • Number of events 30 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
9.8%
24/246 • Number of events 28 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
27/255 • Number of events 30 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
12.2%
30/246 • Number of events 42 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.3%
39/255 • Number of events 39 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
17.9%
44/246 • Number of events 52 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
13/255 • Number of events 14 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.1%
10/246 • Number of events 12 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.5%
19/255 • Number of events 25 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
5.7%
14/246 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.5%
14/255 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.1%
10/246 • Number of events 10 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.5%
14/255 • Number of events 14 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
7.7%
19/246 • Number of events 21 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
19/255 • Number of events 22 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
7.7%
19/246 • Number of events 23 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.9%
10/255 • Number of events 10 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.5%
16/246 • Number of events 18 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.8%
30/255 • Number of events 31 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
13.0%
32/246 • Number of events 37 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Dizziness
|
12.9%
33/255 • Number of events 38 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
13.4%
33/246 • Number of events 44 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Dysgeusia
|
8.6%
22/255 • Number of events 22 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
9.3%
23/246 • Number of events 24 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Headache
|
40.4%
103/255 • Number of events 153 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
41.9%
103/246 • Number of events 150 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
17/255 • Number of events 17 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
5.7%
14/246 • Number of events 17 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Nervous system disorders
Tremor
|
18.0%
46/255 • Number of events 49 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
9.3%
23/246 • Number of events 24 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Psychiatric disorders
Anxiety
|
17.3%
44/255 • Number of events 53 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
16.3%
40/246 • Number of events 42 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Psychiatric disorders
Depression
|
7.1%
18/255 • Number of events 18 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.5%
11/246 • Number of events 11 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Psychiatric disorders
Insomnia
|
29.8%
76/255 • Number of events 85 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
29.3%
72/246 • Number of events 86 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Dysuria
|
11.4%
29/255 • Number of events 33 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.1%
20/246 • Number of events 25 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Haematuria
|
5.9%
15/255 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
2.8%
7/246 • Number of events 8 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Pollakiuria
|
5.5%
14/255 • Number of events 16 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
3.3%
8/246 • Number of events 9 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Renal and urinary disorders
Renal failure
|
6.3%
16/255 • Number of events 17 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.9%
17/246 • Number of events 19 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.5%
60/255 • Number of events 71 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
22.4%
55/246 • Number of events 71 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.3%
44/255 • Number of events 53 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
16.3%
40/246 • Number of events 50 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.0%
23/255 • Number of events 28 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
13.8%
34/246 • Number of events 37 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.8%
20/255 • Number of events 21 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
8.9%
22/246 • Number of events 24 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.9%
10/255 • Number of events 12 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
6.9%
17/246 • Number of events 21 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
18/255 • Number of events 20 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
3.3%
8/246 • Number of events 8 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.1%
41/255 • Number of events 42 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
12.2%
30/246 • Number of events 33 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.3%
16/255 • Number of events 17 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
7.3%
18/246 • Number of events 19 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
11.8%
30/255 • Number of events 32 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
11.8%
29/246 • Number of events 31 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.8%
20/255 • Number of events 20 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
10.2%
25/246 • Number of events 26 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.0%
28/255 • Number of events 37 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
13.8%
34/246 • Number of events 50 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.3%
67/255 • Number of events 85 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
24.0%
59/246 • Number of events 67 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.4%
52/255 • Number of events 61 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
20.7%
51/246 • Number of events 67 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.1%
13/255 • Number of events 17 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
4.9%
12/246 • Number of events 15 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Vascular disorders
Hypertension
|
32.5%
83/255 • Number of events 96 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
26.8%
66/246 • Number of events 78 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
|
Vascular disorders
Hypotension
|
14.1%
36/255 • Number of events 37 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
15.9%
39/246 • Number of events 50 • All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).
Treatment Emergent Adverse Event (TEAE) was defined as an adverse event observed after the first dose of study drug injection through Day 365 and within 30 days of the last dose of study drug. Drug-related TEAE was defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. AE data was not planned to be collected during the long-term follow-up period.
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc.
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER