Trial Outcomes & Findings for Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia (NCT NCT01363297)

Last Updated: 2017-04-13

Results Overview

DLT was any of the following in the first cycle \& attributable to inotuzumab ozogamicin: any greater than or equal to (≥) Grade 4 non-hematologic toxicity except nausea/vomiting (if manageable with supportive care), alopecia, \& toxicities secondary to neutropenia \& sepsis; prolonged myelosuppression (absolute neutrophil count \[ANC\] less than \[\<\] 500 per microliter \[/µL\] or platelet count \<25,000/µL in bone marrow with \<5 percent (%) blasts \& no evidence of leukemia more than 45 days beyond the most recent dose of test article); any Grade 3 non-hematologic toxicity (excluding toxicities such as alopecia or those secondary to neutropenia \& sepsis) not resolving to ≥ Grade 2 within 7 days of the most recent dose of test article or was clinically significant irrespective of duration; any ≥ Grade 3 elevation of alanine aminotransferase, aspartate aminotransferase or bilirubin lasting ≥7 days; any test article related toxicity resulting in permanent discontinuation of test article.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Cycle 1

Results posted on

2017-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles
Overall Study STARTED	3	12	9	13	35
Overall Study COMPLETED	0	6	3	3	4
Overall Study NOT COMPLETED	3	6	6	10	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles
Overall Study Other	0	0	0	0	1
Overall Study Death	3	6	6	10	30

Baseline Characteristics

Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=3 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=12 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=9 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=13 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=35 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Total n=72 Participants Total of all reporting groups
Age, Continuous	63.7 Years STANDARD_DEVIATION 1.53 • n=5 Participants	44.9 Years STANDARD_DEVIATION 18.06 • n=7 Participants	43.1 Years STANDARD_DEVIATION 18.37 • n=5 Participants	53.4 Years STANDARD_DEVIATION 13.82 • n=4 Participants	40.7 Years STANDARD_DEVIATION 17.08 • n=21 Participants	44.9 Years STANDARD_DEVIATION 17.26 • n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	8 Participants n=21 Participants	21 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	27 Participants n=21 Participants	51 Participants n=8 Participants

PRIMARY outcome

Timeframe: Cycle 1

Population: Safety analysis set

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=3 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=12 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=9 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses
Percentage of Participants Reporting Dose Limiting Toxicities (DLTs) During the Phase 1 Dose-Finding Phase	0 Percentage of Participants	0 Percentage of Participants	11.1 Percentage of Participants	—	—	—

PRIMARY outcome

Timeframe: From screening to progressive disease or another induction therapy started, up to approximately 2 years

Population: Safety analysis set

CR was the disappearance of leukemia indicated by \<5% marrow blasts and absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was as for CR except with ANC \<1000/µL and/or platelets \<100,000/µL. PR was an improved or no worsening of acute lymphocytic leukemia indicated by no peripheral blood blasts, and/or at least a 50% decrease in the marrow blast percentage, compared to pre-treatment value, and marrow blast percentage ≥5% and less than or equal to (≤)25% and/or C2 extramedullary disease status. RD occurred if a participant survived ≥7 days following completion of initial treatment course and had persistent leukemia in the most recent peripheral blood smear or bone marrow and/or persistent disease involvement at any extramedullary site after completion of therapy.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=3 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=12 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=9 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses
Percentage of Participants With Preliminary Satisfactory Response (Complete Response [CR], CR With Incomplete Count Recovery [CRi], Partial Response [PR], or Resistant Disease [RD]) Indicating Disease Stability After First Dose During Phase 1 Dose-Finding	100 Percentage of Participants	91.7 Percentage of Participants	88.9 Percentage of Participants	—	—	—

PRIMARY outcome

Timeframe: From screening to progressive disease or another induction therapy started, up to approximately 2 years

Population: Safety analysis set

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=35 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses
Percentage of Participants With CR or CRi During Phase 2	68.6 Percentage of Partcicipants Interval 53.39 to 81.27	—	—	—	—	—

PRIMARY outcome

Timeframe: From screening to progressive disease or another induction therapy started, up to approximately 2 years

Population: Safety analysis set

CR was defined as a disappearance of leukemia as indicated by \<5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC \<1000/µL and/or platelets \<100,000/µL. PR was defined as an improved or no worsening of acute lymphocytic leukemia as indicated by no peripheral blood blasts, and either or both of the following: at least a 50% decrease in the marrow blast percentage, compared to the pre-treatment value, and marrow blast percentage ≥5% and ≤25% and/or C2 extramedullary disease status.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=13 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses
Percentage of Participants With CR, CRi or PR During the Phase 1 Expansion Phase	46.2 Percentage of Partcicipants Interval 19.22 to 74.87	—	—	—	—	—

SECONDARY outcome

Timeframe: From screening to progressive disease or another induction therapy started, up to approximately 2 years

Population: Safety analysis set

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=35 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses
Percentage of Participants With CR, CRi or PR in Phase 2	74.3 Percentage of Partcicipants Interval 56.74 to 87.51	—	—	—	—	—

SECONDARY outcome

Timeframe: From screening to progressive disease or another induction therapy started, up to approximately 2 years

Population: Number of participants who achieved CR and CRi

MRD negativity was defined as \<0.01% mononuclear cells.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=2 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=9 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=8 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=6 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=24 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=49 Participants
Number of Participants With Minimal Residual Disease (MRD) Negativity in Participants Achieving CR and CRi	2 Participants	8 Participants	8 Participants	5 Participants	18 Participants	41 Participants

SECONDARY outcome

Timeframe: From screening to progressive disease or another induction therapy started, up to approximately 2 years

Population: Safety analysis set (n refers to number of participants evaluated)

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=72 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses
Percentage of Participants With CR or CRi by Cytogenetic Category Normal (n=13)	86.7 Percentage of Participants	—	—	—	—	—
Percentage of Participants With CR or CRi by Cytogenetic Category Complex (n=10)	66.7 Percentage of Participants	—	—	—	—	—
Percentage of Participants With CR or CRi by Cytogenetic Category Ph+ (n=9)	56.3 Percentage of Participants	—	—	—	—	—
Percentage of Participants With CR or CRi by Cytogenetic Category Other (n=13)	65.0 Percentage of Participants	—	—	—	—	—
Percentage of Participants With CR or CRi by Cytogenetic Category Unknown (n=3)	75.0 Percentage of Participants	—	—	—	—	—
Percentage of Participants With CR or CRi by Cytogenetic Category Missing (n=1)	50 Percentage of Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 2 years from first dose

Population: Safety analysis set

Post-treatment SCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=3 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=12 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=9 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=13 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=35 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=72 Participants
Percentage of Participants Who Had a Post-Treatment Stem-Cell Transplant (SCT)	0 Percentage of Particicpants	75.0 Percentage of Particicpants	44.4 Percentage of Particicpants	23.1 Percentage of Particicpants	22.9 Percentage of Particicpants	33.3 Percentage of Particicpants

SECONDARY outcome

Timeframe: Up to approximately 2 years from first dose

Population: Safety analysis set

PFS was defined as the time from Cycle 1 Day 1 to first documentation of PFS event (earliest date of objective progression \[PD\], treatment discontinuation due to global deterioration of health status, subsequent induction or transplant after best response of PR or resistant disease, relapse after CR or CRi, or death due to any cause). Participants last known to be 1) alive and 2) without a PFS event, were censored at the date of the last disease assessment that verified lack of event.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=3 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=12 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=9 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=13 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=35 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=72 Participants
Progression Free Survival (PFS)	5.5 Months Interval 2.1 to 6.4	NA Months Interval 1.4 to Median and upper 95% CI may not have been reached at the time of data analysis.	8.8 Months Interval 1.3 to 16.7	1.9 Months Interval 1.0 to 5.0	3.7 Months Interval 2.6 to 4.7	3.9 Months Interval 3.0 to 5.4

SECONDARY outcome

Timeframe: Up to approximately 2 years from first dose

Population: All participants who achieved CR or CRi

DoR1 was defined for participants who responded as the time from the date of first documentation of Complete Hematologic Response (CR or CRi) to the date of the first documentation of relapse after CR or CRi, treatment discontinuation due to global deterioration of health status) or to death due to any cause. Participants last known to be 1) alive and 2) without a DoR1 event, were censored at the date of the last disease assessment that verified lack of event.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=2 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=9 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=8 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=6 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=24 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=49 Participants
Duration of Remission (DoR1) for Participants Who Achieved CR or CRi	4.7 Months Interval 4.6 to 4.8	NA Months Interval 0.7 to Median and upper 95% CI may not have been reached at the time of data analysis.	10.8 Months Interval 1.2 to Upper 95% CI may not have been reached at the time of data analysis.	7.1 Months Interval 2.1 to Upper 95% CI may not have been reached at the time of data analysis.	3.8 Months Interval 2.2 to 5.8	4.8 Months Interval 3.8 to 7.0

SECONDARY outcome

Timeframe: Up to approximately 2 years from first dose

Population: All participants who achieved CR, CRi or PR.

DoR was defined for participants who respond as the time from the date of first documentation of Hematologic Response (CR, CRi, or PR) to the date of the first documentation of DoR event (earliest date of PD, treatment discontinuation due to global deterioration of health status, first induction therapy or transplant after PR, relapse after CR or CRi or death due to any cause). Participants last known to be 1) alive and 2) without a DoR event, were censored at the date of the last disease assessment that verified lack of event.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=2 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=11 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=8 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=6 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=26 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=53 Participants
Duration of Response (DoR) for Participants Who Achieved CR/CRi or PR	20.50 Weeks Interval 20.1 to 20.9	NA Weeks Interval 3.1 to Median and upper 95% CI may not have been reached at the time of data analysis.	46.93 Weeks Interval 7.6 to Upper 95% CI may not have been reached at the time of data analysis.	31.07 Weeks Interval 12.1 to Upper 95% CI may not have been reached at the time of data analysis.	16.57 Weeks Interval 9.9 to 24.0	18.71 Weeks Interval 12.6 to 25.6

SECONDARY outcome

Timeframe: Up to approximately 2 years from first dose

Population: Safety analysis set

OS was defined as the time from Cycle 1 Day 1 to date of death due to any cause. If death was not documented, censoring occurred at the date at which the participant was last known to be alive.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=3 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=12 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=9 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=13 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=35 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=72 Participants
Overall Survival (OS)	9.2 Months Interval 2.1 to 11.3	NA Months Interval 2.6 to Median and upper 95% CI may not have been reached at the time of data analysis.	16.5 Months Interval 2.6 to Upper 95% CI may not have been reached at the time of data analysis.	5.8 Months Interval 3.5 to 10.8	6.4 Months Interval 4.5 to 7.9	7.4 Months Interval 5.7 to 9.2

SECONDARY outcome

Timeframe: Up to approximately 2 years from first dose

Population: All participants who achieved CR or CRi

Time to remission was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic remission (CR or CRi) in participants achieving remission during study therapy.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=2 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=9 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=8 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=6 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=24 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=49 Participants
Time to Remission for Participants Who Achieved CR or CRi	39.0 Days Full Range 24.04 • Interval 22.0 to 56.0	29.0 Days Full Range 12.60 • Interval 22.0 to 59.0	38.0 Days Full Range 19.88 • Interval 22.0 to 78.0	27.0 Days Full Range 29.18 • Interval 21.0 to 85.0	25.5 Days Full Range 22.12 • Interval 15.0 to 91.0	27.0 Days Full Range 20.75 • Interval 15.0 to 91.0

SECONDARY outcome

Timeframe: Up to approximately 2 years from first dose

Population: All participants who achieved CR, CRi or PR.

Time to response was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic response (CR, CRi, or PR).

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=2 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=11 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=8 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=6 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=26 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=53 Participants
Time to Response for Participants Who Achieved CR/CRi or PR	39.0 Days Full Range 24.04 • Interval 22.0 to 56.0	29.0 Days Full Range 9.01 • Interval 22.0 to 49.0	27.0 Days Full Range 20.66 • Interval 20.0 to 78.0	24.0 Days Full Range 10.09 • Interval 21.0 to 48.0	23.0 Days Full Range 10.22 • Interval 15.0 to 58.0	25.0 Days Full Range 12.45 • Interval 15.0 to 78.0

SECONDARY outcome

Timeframe: Screening, Day 21 of Cycles 1 to 6 and up to 4 to 6 weeks after the last dose (up to 34 weeks)

Population: All participants who achieved CR/CRi and MRD negativity.

Time to MRD negativity was defined as the time from the date of first dose of study drug to the date of first documentation of MRD negativity.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=2 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=8 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=8 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=5 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=18 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=41 Participants
Time to MRD Negativity for Participants Who Achieved CR or CRi	98.5 Days Full Range 0.71 • Interval 98.0 to 99.0	32.0 Days Full Range 15.17 • Interval 22.0 to 64.0	30.0 Days Full Range 50.54 • Interval 22.0 to 141.0	25.0 Days Full Range 48.09 • Interval 21.0 to 134.0	25.5 Days Full Range 18.66 • Interval 21.0 to 80.0	29.0 Days Full Range 32.73 • Interval 21.0 to 141.0

SECONDARY outcome

Timeframe: From first dose up to approximately 2 years

Population: Participants who were alive

Duration of follow-up was defined as the time from the date of first dose of study drug to the date of last contact for participants known to be alive.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=6 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=3 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=3 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=5 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=17 Participants
Duration of Follow-Up	—	24.0 Months Interval 22.9 to 29.7	25.7 Months Interval 24.1 to 26.5	24.1 Months Interval 23.9 to 26.9	24.2 Months Interval 6.8 to 24.5	24.1 Months Interval 24.0 to 24.5

SECONDARY outcome

Timeframe: Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4

Population: Safety analysis set

CD22+ leukemic blasts assessed in abnormal B cells from blood (data from central laboratories only).

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=3 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=12 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=9 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=13 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=35 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=72 Participants
Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit Screening	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	93.7 Percentage of CD22+ Interval 88.0 to 100.0	NA Percentage of CD22+ Median and CI not determined since n = 0	93.7 Percentage of CD22+ Interval 88.0 to 100.0
Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit Cycle 1 Day 1	99.7 Percentage of CD22+ Interval 57.0 to 100.0	98.1 Percentage of CD22+ Interval 67.0 to 100.0	98.4 Percentage of CD22+ Interval 0.0 to 100.0	96.4 Percentage of CD22+ Interval 65.0 to 100.0	98.7 Percentage of CD22+ Interval 0.0 to 100.0	98.0 Percentage of CD22+ Interval 0.0 to 100.0
Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit Cycle 1 Day 15	66.2 Percentage of CD22+ Interval 31.0 to 99.0	79.0 Percentage of CD22+ Interval 0.0 to 100.0	0.0 Percentage of CD22+ Interval 0.0 to 99.0	71.4 Percentage of CD22+ Interval 0.0 to 100.0	74.8 Percentage of CD22+ Interval 0.0 to 100.0	69.9 Percentage of CD22+ Interval 0.0 to 100.0
Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit Cycle 2 Day 1	52.0 Percentage of CD22+ Interval 6.0 to 100.0	0.0 Percentage of CD22+ Interval 0.0 to 100.0	0.0 Percentage of CD22+ Interval 0.0 to 92.0	2.8 Percentage of CD22+ Interval 0.0 to 100.0	0.0 Percentage of CD22+ Interval 0.0 to 100.0	0.0 Percentage of CD22+ Interval 0.0 to 100.0
Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit Cycle 2 Day 15	0.0 Percentage of CD22+ Interval 0.0 to 0.0	0.0 Percentage of CD22+ Interval 0.0 to 98.0	0.0 Percentage of CD22+ Interval 0.0 to 0.0	0.5 Percentage of CD22+ Interval 0.0 to 99.0	0.0 Percentage of CD22+ Interval 0.0 to 100.0	0.0 Percentage of CD22+ Interval 0.0 to 100.0
Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit Cycle 4 Day 1	49.2 Percentage of CD22+ Interval 0.0 to 100.0	0.0 Percentage of CD22+ Interval 0.0 to 0.0	0.0 Percentage of CD22+ Interval 0.0 to 73.0	0.0 Percentage of CD22+ Interval 0.0 to 38.0	0.0 Percentage of CD22+ Interval 0.0 to 100.0	0.0 Percentage of CD22+ Interval 0.0 to 100.0
Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit End of Treatment	99.0 Percentage of CD22+ Interval 99.0 to 99.0	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	99.0 Percentage of CD22+ Interval 99.0 to 99.0

SECONDARY outcome

Timeframe: Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4

Population: Safety analysis set

CD22+ leukemic blasts assessed in abnormal B cells from bone marrow (data from central laboratories only).

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=3 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=12 Participants IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=9 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=13 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=35 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses n=72 Participants
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Cycle 5 Day 21	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	0.0 Percentage of CD22+ Interval 0.0 to 0.0	66.4 Percentage of CD22+ Interval 48.0 to 85.0	48.1 Percentage of CD22+ Interval 0.0 to 85.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Screening	99.6 Percentage of CD22+ Interval 96.0 to 100.0	98.7 Percentage of CD22+ Interval 31.0 to 100.0	98.4 Percentage of CD22+ Interval 97.0 to 100.0	95.1 Percentage of CD22+ Interval 52.0 to 100.0	99.2 Percentage of CD22+ Interval 78.0 to 100.0	99.0 Percentage of CD22+ Interval 31.0 to 100.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Cycle 1 Day 21	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	99 Percentage of CD22+ Interval 99.0 to 99.0	56.5 Percentage of CD22+ Interval 39.0 to 74.0	70.7 Percentage of CD22+ Interval 0.0 to 100.0	72.3 Percentage of CD22+ Interval 0.0 to 100.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Cycle 1 Day 28	75.5 Percentage of CD22+ Interval 52.0 to 99.0	54.1 Percentage of CD22+ Interval 0.0 to 100.0	26.5 Percentage of CD22+ Interval 0.0 to 99.0	74.1 Percentage of CD22+ Interval 0.0 to 100.0	94.5 Percentage of CD22+ Interval 20.0 to 100.0	56.6 Percentage of CD22+ Interval 0.0 to 100.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Cycle 2 Day 21	NA Percentage of CD22+ Median and CI not determined since n = 0	0.0 Percentage of CD22+ Interval 0.0 to 0.0	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	0.0 Percentage of CD22+ Interval 0.0 to 96.0	0.0 Percentage of CD22+ Interval 0.0 to 96.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Cycle 2 Day 28	52.9 Percentage of CD22+ Interval 6.0 to 100.0	0.0 Percentage of CD22+ Interval 0.0 to 31.0	0.0 Percentage of CD22+ Interval 0.0 to 72.0	2.9 Percentage of CD22+ Interval 0.0 to 100.0	6.8 Percentage of CD22+ Interval 0.0 to 78.0	0.0 Percentage of CD22+ Interval 0.0 to 100.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Cycle 3 Day 21	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	0.0 Percentage of CD22+ Interval 0.0 to 0.0	0.0 Percentage of CD22+ Interval 0.0 to 0.0	0.0 Percentage of CD22+ Interval 0.0 to 71.0	0.0 Percentage of CD22+ Interval 0.0 to 71.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Cycle 3 Day 28	50.0 Percentage of CD22+ Interval 0.0 to 100.0	0.0 Percentage of CD22+ Interval 0.0 to 0.0	0.0 Percentage of CD22+ Interval 0.0 to 13.0	0.0 Percentage of CD22+ Interval 0.0 to 78.0	25.1 Percentage of CD22+ Interval 0.0 to 50.0	0.0 Percentage of CD22+ Interval 0.0 to 100.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Cycle 4 Day 21	97 Percentage of CD22+ Interval 97.0 to 97.0	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	11.6 Percentage of CD22+ Interval 0.0 to 45.0	23.2 Percentage of CD22+ Interval 0.0 to 97.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Cycle 4 Day 28	0.0 Percentage of CD22+ Interval 0.0 to 0.0	0.0 Percentage of CD22+ Interval 0.0 to 0.0	14.3 Percentage of CD22+ Interval 2.0 to 27.0	29.4 Percentage of CD22+ Interval 0.0 to 59.0	36 Percentage of CD22+ Interval 36.0 to 36.0	1.9 Percentage of CD22+ Interval 0.0 to 59.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Cycle 5 Day 28	0.0 Percentage of CD22+ Interval 0.0 to 0.0	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	79.1 Percentage of CD22+ Interval 0.0 to 99.0	NA Percentage of CD22+ Median and CI not determined since n = 0	39.6 Percentage of CD22+ Interval 0.0 to 99.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit Cycle 6 Day 21	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	NA Percentage of CD22+ Median and CI not determined since n = 0	0.0 Percentage of CD22+ Interval 0.0 to 0.0	74 Percentage of CD22+ Interval 74.0 to 74.0	0.0 Percentage of CD22+ Interval 0.0 to 74.0
Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit End of Treatment	100 Percentage of CD22+ Interval 100.0 to 100.0	0.0 Percentage of CD22+ Interval 0.0 to 4.0	0.0 Percentage of CD22+ Interval 0.0 to 0.0	6.6 Percentage of CD22+ Interval 2.0 to 11.0	0.0 Percentage of CD22+ Interval 0.0 to 94.0	0.0 Percentage of CD22+ Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Predose and postdose on Days 1 and 15 of Cycle 1

Population: Pharmacogenomics population - included all enrolled participants who received at least 1 dose of any study drug, and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment.

Optional blood samples for pharmacogenomic parameters were collected during Cycle 1 prior to the start of the inotuzumab ozogamicin infusion (0 hours) and 1 hour post-dose (original Final Protocol and Protocol Amendments 1 and 2) or 3 hours post-dose (Protocol Amendments 3 and 4) on Day 1 and Day 15 from those participants who provided consent. Gene expression analysis of samples collected pre- and post-dosing was performed using 96-gene TaqMan® low density array cards to examine the concordance between clinical outcome and expression of genes such as those involved in DNA damage response, apoptosis, B-cell antigen expression, glutathione metabolism, drug transport and the phosphoinositide 3-kinase/mammalian target of rapamycin pathway. Expression for each gene was reported as a normalized value, 2\^-change in (∆) threshold cycle (Ct), where ∆Ct is Ct\^target gene minus Ct\^reference genes, averaged.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=55 Participants IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	All Doses
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP2: Cycle 1 Day 1, Baseline (n=55)	0.04235 Fold expression Interval 0.0161 to 0.1661	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP2: Cycle 1 Day 1, Post-dose (n=52)	0.04162 Fold expression Interval 0.0141 to 0.1175	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP2: Cycle 1 Day 15, 0 hours (n=48)	0.03287 Fold expression Interval 0.0201 to 0.1092	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP2: Cycle 1 Day 15, Post-dose (n=46)	0.03283 Fold expression Interval 0.019 to 0.1097	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP3: Cycle 1 Day 1, Baseline (n=55)	0.02380 Fold expression Interval 0.0091 to 0.0608	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP3: Cycle 1 Day 1, Post-dose (n=52)	0.02353 Fold expression Interval 0.0046 to 0.0741	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP3: Cycle 1 Day 15, 0 hours (n=48)	0.02168 Fold expression Interval 0.0102 to 0.0404	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP3: Cycle 1 Day 15, Post-dose (n=46)	0.02030 Fold expression Interval 0.0068 to 0.0429	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP7: Cycle 1 Day 1, Baseline (n=55)	0.01271 Fold expression Interval 0.0032 to 0.0364	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP7: Cycle 1 Day 1, Post-dose (n=52)	0.01354 Fold expression Interval 0.0024 to 0.0278	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP7: Cycle 1 Day 15, 0 hours (n=48)	0.00923 Fold expression Interval 0.0026 to 0.0235	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP7: Cycle 1 Day 15, Post-dose (n=46)	0.00833 Fold expression Interval 0.0016 to 0.0196	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP9: Cycle 1 Day 1, Baseline (n=55)	0.00772 Fold expression Interval 0.0039 to 0.0211	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP9: Cycle 1 Day 1, Post-dose (n=52)	0.00732 Fold expression Interval 0.0033 to 0.0218	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP9: Cycle 1 Day 15, 0 hours (n=48)	0.00707 Fold expression Interval 0.0042 to 0.012	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CASP9: Cycle 1 Day 15, Post-dose (n=46)	0.00715 Fold expression Interval 0.0037 to 0.0135	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CCND1: Cycle 1 Day 1, Baseline (n=52)	0.00091 Fold expression Interval 0.0001 to 0.0309	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CCND1: Cycle 1 Day 1, Post-dose (n=49)	0.00071 Fold expression Interval 0.0001 to 0.0153	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CCND1: Cycle 1 Day 15, 0 hours (n=43)	0.00080 Fold expression Interval 0.0002 to 0.0067	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CCND1: Cycle 1 Day 15, Post-dose (n=37)	0.00078 Fold expression Interval 0.0002 to 0.0044	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CCNE1: Cycle 1 Day 1, Baseline (n=53)	0.00311 Fold expression Interval 0.0003 to 0.0371	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CCNE1: Cycle 1 Day 1, Post-dose (n=50)	0.00331 Fold expression Interval 0.0005 to 0.0318	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CCNE1: Cycle 1 Day 15, 0 hours (n=46)	0.00234 Fold expression Interval 0.0004 to 0.0136	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CCNE1: Cycle 1 Day 15, Post-dose (n=43)	0.00217 Fold expression Interval 0.0002 to 0.008	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD22: Cycle 1 Day 1, Baseline (n=55)	0.04313 Fold expression Interval 0.0005 to 0.7239	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD22: Cycle 1 Day 1, Post-dose (n=51)	0.03359 Fold expression Interval 0.0007 to 0.601	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD22: Cycle 1 Day 15, 0 hours (n=35)	0.00120 Fold expression Interval 0.0002 to 0.0559	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD22: Cycle 1 Day 15, Post-dose (n=32)	0.00130 Fold expression Interval 0.0002 to 0.0684	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD24: Cycle 1 Day 1, Baseline (n=55)	0.31881 Fold expression Interval 0.0232 to 2.6309	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD24: Cycle 1 Day 1, Post-dose (n=52)	0.36597 Fold expression Interval 0.0237 to 3.072	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD24: Cycle 1 Day 15, 0 hours (n=48)	0.02968 Fold expression Interval 0.0019 to 0.5446	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD24: Cycle 1 Day 15, Post-dose (n=46)	0.05363 Fold expression Interval 0.0036 to 0.6901	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD44: Cycle 1 Day 1, Baseline (n=55)	0.25285 Fold expression Interval 0.1254 to 0.8904	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD44: Cycle 1 Day 1, Post-dose (n=52)	0.23497 Fold expression Interval 0.0996 to 0.7828	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD44: Cycle 1 Day 15, 0 hours (n=48)	0.27359 Fold expression Interval 0.1607 to 0.6984	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD44: Cycle 1 Day 15, Post-dose (n=46)	0.22892 Fold expression Interval 0.1309 to 0.6394	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD70: Cycle 1 Day 1, Baseline (n=52)	0.00194 Fold expression Interval 0.0 to 0.0282	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD70: Cycle 1 Day 1, Post-dose (n=47)	0.00170 Fold expression Interval 0.0001 to 0.0291	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD70: Cycle 1 Day 15, 0 hours (n=42)	0.00225 Fold expression Interval 0.0002 to 0.0115	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CD70: Cycle 1 Day 15, Post-dose (n=38)	0.00169 Fold expression Interval 0.0001 to 0.0135	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDC25A: Cycle 1 Day 1, Baseline (n=53)	0.00337 Fold expression Interval 0.0003 to 0.029	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDC25A: Cycle 1 Day 1, Post-dose (n=50)	0.00334 Fold expression Interval 0.0003 to 0.0292	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDC25A: Cycle 1 Day 15, 0 hours (n=45)	0.00115 Fold expression Interval 0.0002 to 0.01	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDC25A: Cycle 1 Day 15, Post-dose (n=36)	0.00116 Fold expression Interval 0.0002 to 0.0098	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDK2: Cycle 1 Day 1, Baseline (n=55)	0.02026 Fold expression Interval 0.0028 to 0.0786	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDK2: Cycle 1 Day 1, Post-dose (n=52)	0.01883 Fold expression Interval 0.0031 to 0.0786	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDK2: Cycle 1 Day 15, 0 hours (n=48)	0.01109 Fold expression Interval 0.0043 to 0.0389	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDK2: Cycle 1 Day 15, Post-dose (n=46)	0.01118 Fold expression Interval 0.0039 to 0.0458	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDKN2A: Cycle 1 Day 1, Baseline (n=55)	0.00675 Fold expression Interval 0.0002 to 0.7546	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDKN2A: Cycle 1 Day 1, Post-dose (n=52)	0.00667 Fold expression Interval 0.0002 to 0.7308	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDKN2A: Cycle 1 Day 15, 0 hours (n=48)	0.00676 Fold expression Interval 0.0001 to 0.0892	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CDKN2A: Cycle 1 Day 15, Post-dose (n=46)	0.00661 Fold expression Interval 0.0001 to 0.1001	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CHEK2: Cycle 1 Day 1, Baseline (n=55)	0.00257 Fold expression Interval 0.0008 to 0.0067	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CHEK2: Cycle 1 Day 1, Post-dose (n=51)	0.00224 Fold expression Interval 0.0008 to 0.0069	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CHEK2: Cycle 1 Day 15, 0 hours (n=47)	0.00206 Fold expression Interval 0.0006 to 0.0077	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CHEK2: Cycle 1 Day 15, Post-dose (n=46)	0.00234 Fold expression Interval 0.0009 to 0.0093	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DAPK1: Cycle 1 Day 1, Baseline (n=55)	0.02015 Fold expression Interval 0.0005 to 0.285	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DAPK1: Cycle 1 Day 1, Post-dose (n=52)	0.02089 Fold expression Interval 0.0002 to 0.233	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DAPK1: Cycle 1 Day 15, 0 hours (n=48)	0.01627 Fold expression Interval 0.0017 to 0.0447	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DAPK1: Cycle 1 Day 15, Post-dose (n=46)	0.01769 Fold expression Interval 0.0018 to 0.0544	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DCLRE1C: Cycle 1 Day 1, Baseline (n=55)	0.01404 Fold expression Interval 0.003 to 0.055	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DCLRE1C: Cycle 1 Day 1, Post-dose (n=52)	0.01226 Fold expression Interval 0.0028 to 0.0539	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DCLRE1C: Cycle 1 Day 15, 0 hours (n=48)	0.00845 Fold expression Interval 0.0034 to 0.0162	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DCLRE1C: Cycle 1 Day 15, Post-dose (n=46)	0.00875 Fold expression Interval 0.0031 to 0.0243	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DDIT4L: Cycle 1 Day 1, Baseline (n=46)	0.00091 Fold expression Interval 0.0001 to 0.0322	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DDIT4L: Cycle 1 Day 1, Post-dose (n=41)	0.00081 Fold expression Interval 0.0001 to 0.0169	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DDIT4L: Cycle 1 Day 15, 0 hours (n=18)	0.00058 Fold expression Interval 0.0002 to 0.0093	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression DDIT4L: Cycle 1 Day 15, Post-dose (n=13)	0.00052 Fold expression Interval 0.0002 to 0.0115	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression EBF1: Cycle 1 Day 1, Baseline (n=55)	0.02830 Fold expression Interval 0.0005 to 0.3909	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression EBF1: Cycle 1 Day 1, Post-dose (n=51)	0.02492 Fold expression Interval 0.0006 to 0.3346	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression EBF1: Cycle 1 Day 15, 0 hours (n=35)	0.00112 Fold expression Interval 0.0001 to 0.0761	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression EBF1: Cycle 1 Day 15, Post-dose (n=34)	0.00112 Fold expression Interval 0.0002 to 0.1217	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression EEF1D: Cycle 1 Day 1, Baseline (n=55)	0.00250 Fold expression Interval 0.0006 to 0.0115	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression EEF1D: Cycle 1 Day 1, Post-dose (n=52)	0.00246 Fold expression Interval 0.0008 to 0.0108	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression EEF1D: Cycle 1 Day 15, 0 hours (n=48)	0.00181 Fold expression Interval 0.0007 to 0.0051	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression EEF1D: Cycle 1 Day 15, Post-dose (n=46)	0.00186 Fold expression Interval 0.001 to 0.0059	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FADD: Cycle 1 Day 1, Baseline (n=55)	0.00436 Fold expression Interval 0.0022 to 0.0192	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FADD: Cycle 1 Day 1, Post-dose (n=52)	0.00487 Fold expression Interval 0.0018 to 0.0309	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FADD: Cycle 1 Day 15, 0 hours (n=48)	0.00434 Fold expression Interval 0.0022 to 0.0117	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FADD: Cycle 1 Day 15, Post-dose (n=46)	0.00477 Fold expression Interval 0.0024 to 0.0127	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FAS: Cycle 1 Day 1, Baseline (n=55)	0.02458 Fold expression Interval 0.0041 to 0.0651	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FAS: Cycle 1 Day 1, Post-dose (n=52)	0.02634 Fold expression Interval 0.0042 to 0.0846	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FAS: Cycle 1 Day 15, 0 hours (n=48)	0.03444 Fold expression Interval 0.0107 to 0.0735	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FAS: Cycle 1 Day 15, Post-dose (n=46)	0.03547 Fold expression Interval 0.0124 to 0.0882	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FASLG: Cycle 1 Day 1, Baseline (n=55)	0.00312 Fold expression Interval 0.0003 to 0.0281	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FASLG: Cycle 1 Day 1, Post-dose (n=52)	0.00343 Fold expression Interval 0.0004 to 0.0248	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FASLG: Cycle 1 Day 15, 0 hours (n=48)	0.00873 Fold expression Interval 0.0004 to 0.0338	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression FASLG: Cycle 1 Day 15, Post-dose (n=46)	0.00820 Fold expression Interval 0.0005 to 0.0259	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GAPDH: Cycle 1 Day 1, Baseline (n=55)	0.77798 Fold expression Interval 0.3626 to 2.3473	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GAPDH: Cycle 1 Day 1, Post-dose (n=52)	0.74570 Fold expression Interval 0.3086 to 1.9921	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GAPDH: Cycle 1 Day 15, 0 hours (n=48)	0.46996 Fold expression Interval 0.3306 to 1.4609	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GAPDH: Cycle 1 Day 15, Post-dose (n=46)	0.43709 Fold expression Interval 0.2622 to 1.3683	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GLI3: Cycle 1 Day 1, Baseline (n=35)	0.00098 Fold expression Interval 0.0001 to 0.0101	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GLI3: Cycle 1 Day 1, Post-dose (n=29)	0.00107 Fold expression Interval 0.0001 to 0.0097	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GLI3: Cycle 1 Day 15, 0 hours (n=10)	0.00041 Fold expression Interval 0.0002 to 0.0051	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GLI3: Cycle 1 Day 15, Post-dose (n=8)	0.00054 Fold expression Interval 0.0004 to 0.007	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTA2: Cycle 1 Day 1, Baseline (n=22)	0.00218 Fold expression Interval 0.0001 to 0.1397	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTA2: Cycle 1 Day 1, Post-dose (n=6)	0.00033 Fold expression Interval 0.0002 to 0.0086	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTA2: Cycle 1 Day 15, Post-dose (n=2)	0.00069 Fold expression Interval 0.0006 to 0.0008	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM1: Cycle 1 Day 1, Baseline (n=37)	0.00958 Fold expression Interval 0.0007 to 0.0394	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM1: Cycle 1 Day 1, Post-dose (n=35)	0.00885 Fold expression Interval 0.0009 to 0.0334	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM1: Cycle 1 Day 15, 0 hours (n=34)	0.00706 Fold expression Interval 0.0004 to 0.037	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM1: Cycle 1 Day 15, Post-dose (n=31)	0.00642 Fold expression Interval 0.0004 to 0.0351	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM4: Cycle 1 Day 1, Baseline (n=54)	0.00260 Fold expression Interval 0.0003 to 0.0132	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM4: Cycle 1 Day 1, Post-dose (n=50)	0.00237 Fold expression Interval 0.0004 to 0.0134	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM4: Cycle 1 Day 15, 0 hours (n=47)	0.00226 Fold expression Interval 0.0005 to 0.0091	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM4: Cycle 1 Day 15, Post-dose (n=44)	0.00225 Fold expression Interval 0.0003 to 0.0098	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM5: Cycle 1 Day 1, Baseline (n=29)	0.00045 Fold expression Interval 0.0 to 0.0078	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM5: Cycle 1 Day 1, Post-dose (n=24)	0.00050 Fold expression Interval 0.0 to 0.0074	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM5: Cycle 1 Day 15, 0 hours (n=19)	0.00065 Fold expression Interval 0.0001 to 0.0049	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTM5: Cycle 1 Day 15, Post-dose (n=19)	0.00094 Fold expression Interval 0.0002 to 0.0051	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTP1: Cycle 1 Day 1, Baseline (n=55)	0.28876 Fold expression Interval 0.0344 to 1.6475	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTP1: Cycle 1 Day 1, Post-dose (n=52)	0.28295 Fold expression Interval 0.0378 to 1.2982	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTP1: Cycle 1 Day 15, 0 hours (n=48)	0.19381 Fold expression Interval 0.0349 to 0.961	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTP1: Cycle 1 Day 15, Post-dose (n=46)	0.19224 Fold expression Interval 0.0276 to 0.9227	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTT1: Cycle 1 Day 1, Baseline (n=40)	0.00061 Fold expression Interval 0.0 to 0.003	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTT1: Cycle 1 Day 1, Post-dose (n=35)	0.00065 Fold expression Interval 0.0001 to 0.0027	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTT1: Cycle 1 Day 15, 0 hours (n=29)	0.00064 Fold expression Interval 0.0002 to 0.0033	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression GSTT1: Cycle 1 Day 15, Post-dose (n=28)	0.00066 Fold expression Interval 0.0002 to 0.0031	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression HRK: Cycle 1 Day 1, Baseline (n=48)	0.00136 Fold expression Interval 0.0001 to 0.0635	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression HRK: Cycle 1 Day 1, Post-dose (n=41)	0.00108 Fold expression Interval 0.0001 to 0.0526	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression HRK: Cycle 1 Day 15, 0 hours (n=11)	0.00075 Fold expression Interval 0.0002 to 0.0041	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression HRK: Cycle 1 Day 15, Post-dose (n=13)	0.00055 Fold expression Interval 0.0001 to 0.006	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression IKZF1: Cycle 1 Day 1, Baseline (n=55)	0.22553 Fold expression Interval 0.0053 to 0.6277	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression IKZF1: Cycle 1 Day 1, Post-dose (n=52)	0.25975 Fold expression Interval 0.0204 to 0.5414	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression IKZF1: Cycle 1 Day 15, 0 hours (n=48)	0.23670 Fold expression Interval 0.0072 to 0.5148	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression IKZF1: Cycle 1 Day 15, Post-dose (n=46)	0.23925 Fold expression Interval 0.0072 to 0.5646	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression KMT2A: Cycle 1 Day 1, Baseline (n=55)	0.03764 Fold expression Interval 0.004 to 0.1704	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression KMT2A: Cycle 1 Day 1, Post-dose (n=52)	0.03459 Fold expression Interval 0.0042 to 0.1663	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression KMT2A: Cycle 1 Day 15, 0 hours (n=48)	0.02499 Fold expression Interval 0.009 to 0.0708	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression KMT2A: Cycle 1 Day 15, Post-dose (n=46)	0.02138 Fold expression Interval 0.0066 to 0.0844	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression KRT20: Cycle 1 Day 1, Baseline (n=2)	0.00018 Fold expression Interval 0.0001 to 0.0002	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression LEF1: Cycle 1 Day 1, Baseline (n=55)	0.18940 Fold expression Interval 0.0077 to 1.728	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression LEF1: Cycle 1 Day 1, Post-dose (n=52)	0.14479 Fold expression Interval 0.0089 to 1.6906	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression LEF1: Cycle 1 Day 15, 0 hours (n=48)	0.07819 Fold expression Interval 0.015 to 0.5602	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression LEF1: Cycle 1 Day 15, Post-dose (n=46)	0.05586 Fold expression Interval 0.0121 to 0.8065	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MCL1: Cycle 1 Day 1, Baseline (n=55)	0.42021 Fold expression Interval 0.139 to 1.0057	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MCL1: Cycle 1 Day 1, Post-dose (n=52)	0.44770 Fold expression Interval 0.1628 to 1.2938	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MCL1: Cycle 1 Day 15, 0 hours (n=48)	0.52160 Fold expression Interval 0.2694 to 1.4203	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MCL1: Cycle 1 Day 15, Post-dose (n=46)	0.61933 Fold expression Interval 0.2389 to 2.6947	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MDC1: Cycle 1 Day 1, Baseline (n=55)	0.01825 Fold expression Interval 0.0012 to 0.0535	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MDC1: Cycle 1 Day 1, Post-dose (n=52)	0.01825 Fold expression Interval 0.0012 to 0.0418	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MDC1: Cycle 1 Day 15, 0 hours (n=48)	0.01109 Fold expression Interval 0.0027 to 0.0346	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MDC1: Cycle 1 Day 15, Post-dose (n=46)	0.01034 Fold expression Interval 0.0022 to 0.0411	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MRE11A: Cycle 1 Day 1, Baseline (n=55)	0.00708 Fold expression Interval 0.001 to 0.021	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MRE11A: Cycle 1 Day 1, Post-dose (n=52)	0.00672 Fold expression Interval 0.001 to 0.0277	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MRE11A: Cycle 1 Day 15, 0 hours (n=48)	0.00484 Fold expression Interval 0.0017 to 0.0109	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MRE11A: Cycle 1 Day 15, Post-dose (n=46)	0.00508 Fold expression Interval 0.0017 to 0.0147	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MTOR: Cycle 1 Day 1, Baseline (n=55)	0.01585 Fold expression Interval 0.0027 to 0.0498	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MTOR: Cycle 1 Day 1, Post-dose (n=52)	0.01636 Fold expression Interval 0.0029 to 0.0521	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MTOR: Cycle 1 Day 15, 0 hours (n=48)	0.01088 Fold expression Interval 0.0048 to 0.0288	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression MTOR: Cycle 1 Day 15, Post-dose (n=46)	0.01122 Fold expression Interval 0.0041 to 0.0513	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NHEJ1: Cycle 1 Day 1, Baseline (n=55)	0.01162 Fold expression Interval 0.0026 to 0.0353	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NHEJ1: Cycle 1 Day 1, Post-dose (n=52)	0.01164 Fold expression Interval 0.003 to 0.0352	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NHEJ1: Cycle 1 Day 15, 0 hours (n=48)	0.00974 Fold expression Interval 0.004 to 0.0233	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NHEJ1: Cycle 1 Day 15, Post-dose (n=46)	0.01008 Fold expression Interval 0.0034 to 0.0271	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NLRP2: Cycle 1 Day 1, Baseline (n=55)	0.00237 Fold expression Interval 0.0002 to 0.0181	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NLRP2: Cycle 1 Day 1, Post-dose (n=52)	0.00226 Fold expression Interval 0.0004 to 0.0168	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NLRP2: Cycle 1 Day 15, 0 hours (n=47)	0.00301 Fold expression Interval 0.0002 to 0.0091	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NLRP2: Cycle 1 Day 15, Post-dose (n=46)	0.00283 Fold expression Interval 0.0002 to 0.0084	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NOXA1: Cycle 1 Day 1, Baseline (n=52)	0.00097 Fold expression Interval 0.0001 to 0.0079	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NOXA1: Cycle 1 Day 1, Post-dose (n=48)	0.00107 Fold expression Interval 0.0001 to 0.0069	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NOXA1: Cycle 1 Day 15, 0 hours (n=43)	0.00132 Fold expression Interval 0.0003 to 0.0032	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression NOXA1: Cycle 1 Day 15, Post-dose (n=42)	0.00117 Fold expression Interval 0.0003 to 0.0032	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PAX5: Cycle 1 Day 1, Baseline (n=55)	0.05536 Fold expression Interval 0.0004 to 1.1631	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PAX5: Cycle 1 Day 1, Post-dose (n=52)	0.04433 Fold expression Interval 0.0007 to 0.8454	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PAX5: Cycle 1 Day 15, 0 hours (n=30)	0.00511 Fold expression Interval 0.0002 to 0.1024	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PAX5: Cycle 1 Day 15, Post-dose (n=31)	0.00369 Fold expression Interval 0.0001 to 0.2123	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PDE4A: Cycle 1 Day 1, Baseline (n=55)	0.00738 Fold expression Interval 0.0012 to 0.0578	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PDE4A: Cycle 1 Day 1, Post-dose (n=52)	0.00722 Fold expression Interval 0.0007 to 0.0566	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PDE4A: Cycle 1 Day 15, 0 hours (n=48)	0.00916 Fold expression Interval 0.0019 to 0.0202	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PDE4A: Cycle 1 Day 15, Post-dose (n=46)	0.00836 Fold expression Interval 0.0025 to 0.0235	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PGK1: Cycle 1 Day 1, Baseline (n=55)	0.19043 Fold expression Interval 0.127 to 0.549	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PGK1: Cycle 1 Day 1, Post-dose (n=52)	0.18772 Fold expression Interval 0.1103 to 0.5287	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PGK1: Cycle 1 Day 15, 0 hours (n=48)	0.14989 Fold expression Interval 0.0898 to 0.2804	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PGK1: Cycle 1 Day 15, Post-dose (n=46)	0.14783 Fold expression Interval 0.0649 to 0.2701	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PIK3CA: Cycle 1 Day 1, Baseline (n=55)	0.01664 Fold expression Interval 0.0057 to 0.0496	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PIK3CA: Cycle 1 Day 1, Post-dose (n=52)	0.01714 Fold expression Interval 0.0066 to 0.0535	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PIK3CA: Cycle 1 Day 15, 0 hours (n=48)	0.01154 Fold expression Interval 0.0068 to 0.029	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PIK3CA: Cycle 1 Day 15, Post-dose (n=46)	0.01164 Fold expression Interval 0.0053 to 0.0273	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PRKDC: Cycle 1 Day 1, Baseline (n=55)	0.03206 Fold expression Interval 0.0023 to 0.1691	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PRKDC: Cycle 1 Day 1, Post-dose (n=52)	0.03543 Fold expression Interval 0.0023 to 0.1525	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PRKDC: Cycle 1 Day 15, 0 hours (n=48)	0.01964 Fold expression Interval 0.0049 to 0.0638	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression PRKDC: Cycle 1 Day 15, Post-dose (n=46)	0.02159 Fold expression Interval 0.0051 to 0.0826	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD50: Cycle 1 Day 1, Baseline (n=55)	0.01482 Fold expression Interval 0.0017 to 0.0593	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD50: Cycle 1 Day 1, Post-dose (n=52)	0.01516 Fold expression Interval 0.0019 to 0.0525	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD50: Cycle 1 Day 15, 0 hours (n=48)	0.01129 Fold expression Interval 0.0041 to 0.0238	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD50: Cycle 1 Day 15, Post-dose (n=46)	0.01044 Fold expression Interval 0.0026 to 0.0244	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD51: Cycle 1 Day 1, Baseline (n=54)	0.00558 Fold expression Interval 0.0015 to 0.0484	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD51: Cycle 1 Day 1, Post-dose (n=51)	0.00573 Fold expression Interval 0.001 to 0.0502	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD51: Cycle 1 Day 15, 0 hours (n=47)	0.00382 Fold expression Interval 0.0009 to 0.0222	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD51: Cycle 1 Day 15, Post-dose (n=45)	0.00356 Fold expression Interval 0.0004 to 0.0225	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD52: Cycle 1 Day 1, Baseline (n=55)	0.00384 Fold expression Interval 0.0007 to 0.0129	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD52: Cycle 1 Day 1, Post-dose (n=52)	0.00330 Fold expression Interval 0.0006 to 0.0115	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD52: Cycle 1 Day 15, 0 hours (n=48)	0.00221 Fold expression Interval 0.0008 to 0.0184	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RAD52: Cycle 1 Day 15, Post-dose (n=46)	0.00211 Fold expression Interval 0.0006 to 0.0085	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RB1: Cycle 1 Day 1, Baseline (n=55)	0.03434 Fold expression Interval 0.005 to 0.1631	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RB1: Cycle 1 Day 1, Post dose (n=52)	0.03384 Fold expression Interval 0.0059 to 0.1365	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RB1: Cycle 1 Day 15, 0 hours (n=48)	0.01926 Fold expression Interval 0.0139 to 0.0579	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RB1: Cycle 1 Day 15, Post-dose (n=46)	0.01978 Fold expression Interval 0.0111 to 0.0887	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RHEB: Cycle 1 Day 1, Baseline (n=55)	0.02719 Fold expression Interval 0.0075 to 0.2452	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RHEB: Cycle 1 Day 1, Post-dose (n=52)	0.02287 Fold expression Interval 0.0078 to 0.1474	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RHEB: Cycle 1 Day 15, 0 hours (n=48)	0.01810 Fold expression Interval 0.011 to 0.0377	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RHEB: Cycle 1 Day 15, Post-dose (n=46)	0.01835 Fold expression Interval 0.0107 to 0.0355	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RPA1: Cycle 1 Day 1, Baseline (n=55)	0.05178 Fold expression Interval 0.0097 to 0.1037	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RPA1: Cycle 1 Day 1, Post-dose (n=52)	0.05041 Fold expression Interval 0.0091 to 0.0897	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RPA1: Cycle 1 Day 15, 0 hours (n=48)	0.05348 Fold expression Interval 0.0262 to 0.1692	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression RPA1: Cycle 1 Day 15, Post-dose (n=46)	0.05547 Fold expression Interval 0.0261 to 0.1925	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression SMAD1: Cycle 1 Day 1, Baseline (n=55)	0.00858 Fold expression Interval 0.0001 to 0.138	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression SMAD1: Cycle 1 Day 1, Post-dose (n=51)	0.01116 Fold expression Interval 0.0003 to 0.1996	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression SMAD1: Cycle 1 Day 15, 0 hours (n=47)	0.00167 Fold expression Interval 0.0004 to 0.0377	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression SMAD1: Cycle 1 Day 15, Post-dose (n=46)	0.00197 Fold expression Interval 0.0004 to 0.0552	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression SYK: Cycle 1 Day 1, Baseline (n=55)	0.06101 Fold expression Interval 0.0297 to 0.1445	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression SYK: Cycle 1 Day 1, Post-dose (n=52)	0.05995 Fold expression Interval 0.0256 to 0.1346	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression SYK: Cycle 1 Day 15, 0 hours (n=48)	0.04237 Fold expression Interval 0.0123 to 0.0918	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression SYK: Cycle 1 Day 15, Post-dose (n=46)	0.04603 Fold expression Interval 0.0166 to 0.0979	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TCF3: Cycle 1 Day 1, Baseline (n=55)	0.09144 Fold expression Interval 0.0121 to 0.5337	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TCF3: Cycle 1 Day 1, Post-dose (n=52)	0.07770 Fold expression Interval 0.0138 to 0.4363	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TCF3: Cycle 1 Day 15, 0 hours (n=48)	0.04216 Fold expression Interval 0.0119 to 0.1552	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TCF3: Cycle 1 Day 15, Post-dose (n=46)	0.05154 Fold expression Interval 0.0126 to 0.2377	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TNF: Cycle 1 Day 1, Baseline (n=55)	0.00465 Fold expression Interval 0.0004 to 0.0335	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TNF: Cycle 1 Day 1, Post-dose (n=52)	0.00330 Fold expression Interval 0.0004 to 0.0262	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TNF: Cycle 1 Day 15, 0 hours (n=48)	0.00376 Fold expression Interval 0.0011 to 0.023	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TNF: Cycle 1 Day 15, Post-dose (n=46)	0.00262 Fold expression Interval 0.0009 to 0.017	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TP53: Cycle 1 Day 1, Baseline (n=55)	0.05412 Fold expression Interval 0.0013 to 0.3051	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TP53: Cycle 1 Day 1, Post-dose (n=52)	0.04778 Fold expression Interval 0.002 to 0.2639	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TP53: Cycle 1 Day 15, 0 hours (n=48)	0.03196 Fold expression Interval 0.0085 to 0.0892	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TP53: Cycle 1 Day 15, Post-dose (n=46)	0.02741 Fold expression Interval 0.0052 to 0.0826	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TP53BP1: Cycle 1 Day 1, Baseline (n=55)	0.00386 Fold expression Interval 0.0005 to 0.0233	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TP53BP1: Cycle 1 Day 1, Post-dose (n=52)	0.00373 Fold expression Interval 0.0005 to 0.0214	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TP53BP1: Cycle 1 Day 15, 0 hours (n=48)	0.00205 Fold expression Interval 0.0009 to 0.007	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression TP53BP1: Cycle 1 Day 15, Post-dose (n=46)	0.00182 Fold expression Interval 0.0008 to 0.0098	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression VDAC3: Cycle 1 Day 1, Baseline (n=55)	0.03899 Fold expression Interval 0.0095 to 0.1133	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression VDAC3: Cycle 1 Day 1, Post-dose (n=52)	0.03701 Fold expression Interval 0.0114 to 0.1126	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression VDAC3: Cycle 1 Day 15, 0 hours (n=48)	0.03748 Fold expression Interval 0.0192 to 0.0671	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression VDAC3: Cycle 1 Day 15, Post-dose (n=46)	0.03621 Fold expression Interval 0.0189 to 0.0689	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression VPREB1: Cycle 1 Day 1, Baseline (n=52)	0.08210 Fold expression Interval 0.0004 to 1.7113	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression VPREB1: Cycle 1 Day 1, Post-dose (n=47)	0.08593 Fold expression Interval 0.0001 to 1.8106	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression VPREB1: Cycle 1 Day 15, 0 hours (n=25)	0.00472 Fold expression Interval 0.0003 to 0.3317	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCC2: Cycle 1 Day 1, Baseline (n=53)	0.00064 Fold expression Interval 0.0002 to 0.002	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCC2: Cycle 1 Day 1, Post-dose (n=48)	0.00072 Fold expression Interval 0.0002 to 0.002	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCB1: Cycle 1 Day 1, Baseline (n=55)	0.00421 Fold expression Interval 0.0002 to 0.0217	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCB1: Cycle 1 Day 1, Post-dose (n=51)	0.00440 Fold expression Interval 0.0003 to 0.0313	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCB1: Cycle 1 Day 15, 0 hours (n=48)	0.00746 Fold expression Interval 0.0004 to 0.0218	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCB1: Cycle 1 Day 15, Post-dose (n=46)	0.00783 Fold expression Interval 0.0005 to 0.0364	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCC1: Cycle 1 Day 1, Baseline (n=55)	0.01983 Fold expression Interval 0.0041 to 0.0885	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCC1: Cycle 1 Day 1, Post-dose (n=52)	0.02245 Fold expression Interval 0.0044 to 0.0737	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCC1: Cycle 1 Day 15, 0 hours (n=48)	0.01453 Fold expression Interval 0.0062 to 0.0413	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCC1: Cycle 1 Day 15, Post-dose (n=46)	0.01497 Fold expression Interval 0.0042 to 0.0578	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCC2: Cycle 1 Day 15, 0 hours (n=40)	0.00072 Fold expression Interval 0.0002 to 0.0015	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCC2: Cycle 1 Day 15, Post-dose (n=38)	0.00078 Fold expression Interval 0.0003 to 0.0023	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCG2: Cycle 1 Day 1, Baseline (n=55)	0.00491 Fold expression Interval 0.0003 to 0.0509	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCG2: Cycle 1 Day 1, Post-dose (n=51)	0.00660 Fold expression Interval 0.0002 to 0.0431	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCG2: Cycle 1 Day 15, 0 hours (n=46)	0.01582 Fold expression Interval 0.0014 to 0.0818	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABCG2: Cycle 1 Day 15, Post-dose (n=45)	0.01845 Fold expression Interval 0.001 to 0.0921	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABL1: Cycle 1 Day 1, Baseline (n=55)	0.03297 Fold expression Interval 0.0027 to 0.1982	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABL1: Cycle 1 Day 1, Post-dose (n=52)	0.02899 Fold expression Interval 0.0032 to 0.1382	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABL1: Cycle 1 Day 15, 0 hours (n=48)	0.01369 Fold expression Interval 0.0043 to 0.0632	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABL1: Cycle 1 Day 15, Post-dose (n=46)	0.01381 Fold expression Interval 0.0032 to 0.0783	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABL2: Cycle 1 Day 1, Baseline (n=55)	0.00916 Fold expression Interval 0.0029 to 0.0329	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABL2: Cycle 1 Day 1, Post-dose (n=52)	0.00867 Fold expression Interval 0.0021 to 0.0268	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABL2: Cycle 1 Day 15, 0 hours (n=48)	0.00613 Fold expression Interval 0.0032 to 0.0184	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ABL2: Cycle 1 Day 15, Post-dose (n=46)	0.00547 Fold expression Interval 0.0029 to 0.0224	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ACTB: Cycle 1 Day 1, Baseline (n=55)	1.73899 Fold expression Interval 0.5853 to 4.0764	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ACTB: Cycle 1 Day 1, Post-dose (n=52)	1.95092 Fold expression Interval 0.7314 to 3.3585	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ACTB: Cycle 1 Day 15, 0 hours (n=48)	2.14694 Fold expression Interval 1.3915 to 5.3955	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ACTB: Cycle 1 Day 15, Post-dose (n=46)	2.11584 Fold expression Interval 1.3279 to 7.3316	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression AKT1: Cycle 1 Day 1, Baseline (n=55)	0.03212 Fold expression Interval 0.0112 to 0.0793	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression AKT1: Cycle 1 Day 1, Post-dose (n=52)	0.03164 Fold expression Interval 0.0116 to 0.0738	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression AKT1: Cycle 1 Day 15, 0 hours (n=48)	0.02740 Fold expression Interval 0.0108 to 0.0572	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression AKT1: Cycle 1 Day 15, Post-dose (n=46)	0.02987 Fold expression Interval 0.0078 to 0.0672	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ALG5: Cycle 1 Day 1, Baseline (n=55)	0.00455 Fold expression Interval 0.0004 to 0.0206	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ALG5: Cycle 1 Day 1, Post-dose (n=52)	0.00419 Fold expression Interval 0.0007 to 0.0173	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ALG5: Cycle 1 Day 15, 0 hours (n=48)	0.00302 Fold expression Interval 0.0013 to 0.0064	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ALG5: Cycle 1 Day 15, Post-dose (n=46)	0.00265 Fold expression Interval 0.0006 to 0.006	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression APAF1: Cycle 1 Day 1, Baseline (n=55)	0.03880 Fold expression Interval 0.0074 to 0.0896	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression APAF1: Cycle 1 Day 1, Post-dose (n=52)	0.03740 Fold expression Interval 0.0072 to 0.1051	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression APAF1: Cycle 1 Day 15, 0 hours (n=48)	0.03754 Fold expression Interval 0.0138 to 0.0763	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression APAF1: Cycle 1 Day 15, Post-dose (n=46)	0.03708 Fold expression Interval 0.0128 to 0.0918	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ATM: Cycle 1 Day 1, Baseline (n=55)	0.06441 Fold expression Interval 0.0121 to 0.1845	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ATM: Cycle 1 Day 1, Post-dose (n=52)	0.06615 Fold expression Interval 0.0125 to 0.1497	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ATM: Cycle 1 Day 15, 0 hours (n=48)	0.06927 Fold expression Interval 0.0297 to 0.1439	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ATM: Cycle 1 Day 15, Post-dose (n=46)	0.05951 Fold expression Interval 0.0262 to 0.1247	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ATRX: Cycle 1 Day 1, Baseline (n=55)	0.06123 Fold expression Interval 0.0177 to 0.2406	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ATRX: Cycle 1 Day 1, Post-dose (n=52)	0.05679 Fold expression Interval 0.0194 to 0.2183	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ATRX: Cycle 1 Day 15, 0 hours (n=48)	0.05456 Fold expression Interval 0.0179 to 0.1074	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ATRX: Cycle 1 Day 15, Post-dose (n=46)	0.05662 Fold expression Interval 0.0211 to 0.1142	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression B2M: Cycle 1 Day 1, Baseline (n=55)	3.81650 Fold expression Interval 1.2559 to 9.9074	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression B2M: Cycle 1 Day 1, Post-dose (n=52)	3.89919 Fold expression Interval 1.2108 to 11.9448	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression B2M: Cycle 1 Day 15, 0 hours (n=48)	5.97465 Fold expression Interval 1.1943 to 10.8448	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression B2M: Cycle 1 Day 15, Post-dose (n=46)	6.21338 Fold expression Interval 1.5174 to 12.9707	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAD: Cycle 1 Day 1, Baseline (n=55)	0.00099 Fold expression Interval 0.0004 to 0.0053	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAD: Cycle 1 Day 1, Post-dose (n=52)	0.00100 Fold expression Interval 0.0003 to 0.0067	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAD: Cycle 1 Day 15, 0 hours (n=47)	0.00085 Fold expression Interval 0.0003 to 0.0021	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAD: Cycle 1 Day 15, Post-dose (n=43)	0.00077 Fold expression Interval 0.0004 to 0.0026	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAK1: Cycle 1 Day 1, Baseline (n=55)	0.01991 Fold expression Interval 0.0031 to 0.2253	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAK1: Cycle 1 Day 1, Post-dose (n=52)	0.01658 Fold expression Interval 0.0024 to 0.157	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAK1: Cycle 1 Day 15, 0 hours (n=48)	0.01490 Fold expression Interval 0.005 to 0.0313	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAK1: Cycle 1 Day 15, Post-dose (n=46)	0.01405 Fold expression Interval 0.0045 to 0.0302	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAX: Cycle 1 Day 1, Baseline (n=55)	0.07686 Fold expression Interval 0.029 to 0.1825	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAX: Cycle 1 Day 1, Post-dose (n=52)	0.07420 Fold expression Interval 0.0284 to 0.1904	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAX: Cycle 1 Day 15, 0 hours (n=48)	0.07107 Fold expression Interval 0.0346 to 0.1387	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BAX: Cycle 1 Day 15, Post-dose (n=46)	0.06543 Fold expression Interval 0.0304 to 0.1316	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BBC3: Cycle 1 Day 1, Baseline (n=55)	0.01174 Fold expression Interval 0.0031 to 0.0445	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BBC3: Cycle 1 Day 1, Post-dose (n=52)	0.01197 Fold expression Interval 0.0044 to 0.0384	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BBC3: Cycle 1 Day 15, 0 hours (n=48)	0.01470 Fold expression Interval 0.0052 to 0.0335	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BBC3: Cycle 1 Day 15, Post-dose (n=46)	0.01449 Fold expression Interval 0.0061 to 0.039	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2: Cycle 1 Day 1, Baseline (n=55)	0.02425 Fold expression Interval 0.0021 to 0.0958	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2: Cycle 1 Day 1, Post-dose (n=52)	0.02200 Fold expression Interval 0.0024 to 0.1014	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2: Cycle 1 Day 15, 0 hours (n=48)	0.01979 Fold expression Interval 0.0037 to 0.0703	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2: Cycle 1 Day 15, Post-dose (n=46)	0.01648 Fold expression Interval 0.0042 to 0.0851	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2L1: Cycle 1 Day 1, Baseline (n=55)	0.83473 Fold expression Interval 0.0227 to 11.2775	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2L1: Cycle 1 Day 1, Post-dose (n=52)	1.12931 Fold expression Interval 0.02 to 14.5203	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2L1: Cycle 1 Day 15, 0 hours (n=48)	3.05721 Fold expression Interval 0.0236 to 15.0024	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2L1: Cycle 1 Day 15, Post-dose (n=46)	3.98955 Fold expression Interval 0.022 to 18.3879	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2L11: Cycle 1 Day 1, Baseline (n=55)	0.03003 Fold expression Interval 0.0025 to 0.1197	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2L11: Cycle 1 Day 1, Post-dose (n=52)	0.02970 Fold expression Interval 0.0029 to 0.0916	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2L11: Cycle 1 Day 15, 0 hours (n=48)	0.03865 Fold expression Interval 0.0151 to 0.0817	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCL2L11: Cycle 1 Day 15, Post-dose (n=46)	0.04259 Fold expression Interval 0.0164 to 0.0825	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCR: Cycle 1 Day 1, Baseline (n=7)	0.02294 Fold expression Interval 0.0006 to 0.0858	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCR: Cycle 1 Day 1, Post-dose (n=5)	0.02135 Fold expression Interval 0.0008 to 0.0967	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCR: Cycle 1 Day 15, 0 hours (n=3)	0.00116 Fold expression Interval 0.0003 to 0.0108	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BCR: Cycle 1 Day 15, Post-dose (n=2)	0.00817 Fold expression Interval 0.0013 to 0.015	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BID: Cycle 1 Day 1, Baseline (n=55)	0.01794 Fold expression Interval 0.0076 to 0.0458	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BID: Cycle 1 Day 1, Post-dose (n=52)	0.01528 Fold expression Interval 0.006 to 0.0436	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BID: Cycle 1 Day 15, 0 hours (n=48)	0.01619 Fold expression Interval 0.0071 to 0.0313	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BID: Cycle 1 Day 15, Post-dose (n=46)	0.01448 Fold expression Interval 0.0043 to 0.0518	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BIK: Cycle 1 Day 1, Baseline (n=52)	0.00137 Fold expression Interval 0.0001 to 0.022	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BIK: Cycle 1 Day 1, Post-dose (n=49)	0.00143 Fold expression Interval 0.0001 to 0.0228	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BIK: Cycle 1 Day 15, 0 hours (n=42)	0.00093 Fold expression Interval 0.0005 to 0.0038	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BIK: Cycle 1 Day 15, Post-dose (n=39)	0.00095 Fold expression Interval 0.0004 to 0.0049	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BMF: Cycle 1 Day 1, Baseline (n=55)	0.00604 Fold expression Interval 0.0011 to 0.0579	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BMF: Cycle 1 Day 1, Post-dose (n=52)	0.00705 Fold expression Interval 0.0009 to 0.0807	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BMF: Cycle 1 Day 15, 0 hours (n=47)	0.00333 Fold expression Interval 0.001 to 0.0156	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BMF: Cycle 1 Day 15, Post-dose (n=46)	0.00341 Fold expression Interval 0.0006 to 0.0429	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BRCA1: Cycle 1 Day 1, Baseline (n=55)	0.00628 Fold expression Interval 0.0017 to 0.0395	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BRCA1: Cycle 1 Day 1, Post-dose (n=52)	0.00691 Fold expression Interval 0.0019 to 0.0367	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BRCA1: Cycle 1 Day 15, 0 hours (n=48)	0.00385 Fold expression Interval 0.0019 to 0.0133	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BRCA1: Cycle 1 Day 15, Post-dose (n=46)	0.00416 Fold expression Interval 0.0024 to 0.0175	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BRCA2: Cycle 1 Day 1, Baseline (n=50)	0.00059 Fold expression Interval 0.0002 to 0.0023	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BRCA2: Cycle 1 Day 1, Post-dose (n=44)	0.00067 Fold expression Interval 0.0002 to 0.002	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BRCA2: Cycle 1 Day 15, 0 hours (n=34)	0.00045 Fold expression Interval 0.0003 to 0.0015	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression BRCA2: Cycle 1 Day 15, Post-dose (n=35)	0.00049 Fold expression Interval 0.0003 to 0.0012	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CA6: Cycle 1 Day 1, Baseline (n=48)	0.00104 Fold expression Interval 0.0001 to 0.1076	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CA6: Cycle 1 Day 1, Post-dose (n=42)	0.00196 Fold expression Interval 0.0 to 0.1364	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CA6: Cycle 1 Day 15, 0 hours (n=35)	0.00130 Fold expression Interval 0.0002 to 0.0425	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression CA6: Cycle 1 Day 15, Post-dose (n=34)	0.00119 Fold expression Interval 0.0003 to 0.0576	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression VPREB1: Cycle 1 Day 15, Post-dose (n=28)	0.00332 Fold expression Interval 0.0003 to 0.4981	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC2: Cycle 1 Day 1, Baseline (n=54)	0.00260 Fold expression Interval 0.0002 to 0.023	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC2: Cycle 1 Day 1, Post-dose (n=51)	0.00297 Fold expression Interval 0.0003 to 0.0247	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC2: Cycle 1 Day 15, 0 hours (n=47)	0.00125 Fold expression Interval 0.0003 to 0.0119	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC2: Cycle 1 Day 15, Post-dose (n=43)	0.00124 Fold expression Interval 0.0003 to 0.0105	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC3: Cycle 1 Day 1, Baseline (n=55)	0.00213 Fold expression Interval 0.0002 to 0.0143	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC3: Cycle 1 Day 1, Post-dose (n=50)	0.00205 Fold expression Interval 0.0002 to 0.0127	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC3: Cycle 1 Day 15, 0 hours (n=46)	0.00110 Fold expression Interval 0.0003 to 0.0048	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC3: Cycle 1 Day 15, Post-dose (n=43)	0.00103 Fold expression Interval 0.0002 to 0.0065	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC4: Cycle 1 Day 1, Baseline (n=55)	0.00175 Fold expression Interval 0.0004 to 0.0038	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC4: Cycle 1 Day 1, Post-dose (n=52)	0.00183 Fold expression Interval 0.0004 to 0.0043	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC4: Cycle 1 Day 15, 0 hours (n=47)	0.00172 Fold expression Interval 0.0004 to 0.0035	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC4: Cycle 1 Day 15, Post-dose (n=46)	0.00179 Fold expression Interval 0.0006 to 0.0038	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC5: Cycle 1 Day 1, Baseline (n=55)	0.22952 Fold expression Interval 0.0881 to 0.5646	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC5: Cycle 1 Day 15, 0 hours (n=48)	0.18735 Fold expression Interval 0.1152 to 0.292	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC5: Cycle 1 Day 15, Post-dose (n=46)	0.17577 Fold expression Interval 0.104 to 0.2685	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC6: Cycle 1 Day 1, Baseline (n=55)	0.07688 Fold expression Interval 0.0117 to 0.21	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC6: Cycle 1 Day 1, Post-dose (n=52)	0.06620 Fold expression Interval 0.0109 to 0.1937	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC6: Cycle 1 Day 15, 0 hours (n=48)	0.04898 Fold expression Interval 0.0163 to 0.1503	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC6: Cycle 1 Day 15, Post-dose (n=46)	0.04495 Fold expression Interval 0.0126 to 0.1489	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ZAP70: Cycle 1 Day 1, Baseline (n=55)	0.11022 Fold expression Interval 0.0156 to 0.4971	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ZAP70: Cycle 1 Day 1, Post-dose (n=52)	0.10939 Fold expression Interval 0.0169 to 0.4442	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ZAP70: Cycle 1 Day 15, 0 hours (n=48)	0.18066 Fold expression Interval 0.0082 to 0.5237	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression ZAP70: Cycle 1 Day 15, Post-dose (n=46)	0.15080 Fold expression Interval 0.0083 to 0.5991	—	—	—	—	—
Messenger Ribonucleic Acid (mRNA) Gene Expression XRCC5: Cycle 1 Day 1, Post-dose (n=52)	0.22401 Fold expression Interval 0.0842 to 0.526	—	—	—	—	—

Adverse Events

Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2

Serious events: 8 serious events

Other events: 9 other events

Deaths: 0 deaths

Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2

Serious events: 10 serious events

Other events: 10 other events

Deaths: 0 deaths

Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2

Serious events: 26 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=3 participants at risk IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=12 participants at risk IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=9 participants at risk IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=13 participants at risk IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=35 participants at risk IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles
Blood and lymphatic system disorders Febrile neutropenia	66.7% 2/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	38.5% 5/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.9% 8/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Ear and labyrinth disorders Deafness	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Ascites	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	15.4% 2/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Colitis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Constipation	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Oral disorder	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Disease progression	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Pyrexia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Hepatobiliary disorders Cholangitis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Hepatobiliary disorders Cholecystitis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Hepatobiliary disorders Venoocclusive liver disease	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Abscess limb	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Bacteraemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Cellulitis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Device related infection	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Enterococcal bacteraemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Necrotising fasciitis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Periorbital cellulitis	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Pneumonia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	14.3% 5/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Pneumonia fungal	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Pneumonia influenzal	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Septic shock	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Staphylococcal sepsis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Stenotrophomonas sepsis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Encephalopathy	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system neoplasm	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Headache	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Neurological symptom	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Presyncope	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Syncope	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Psychiatric disorders Confusional state	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Psychiatric disorders Mental status changes	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Renal and urinary disorders Acute kidney injury	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Vascular disorders Hypertension	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.

Other adverse events

Other adverse events
Measure	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2 n=3 participants at risk IV inotuzumab ozogamicin 1.2 mg/m\^2 given in 2 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Day 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2 n=12 participants at risk IV inotuzumab ozogamicin 1.6 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.4 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=9 participants at risk IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2 n=13 participants at risk IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles	Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2 n=35 participants at risk IV inotuzumab ozogamicin 1.8 mg/m\^2 given in 3 doses over a 28-day cycle (0.8 mg/m\^2 on Day 1 and 0.5 mg/m\^2 on Days 8 and 15) for a maximum of 6 cycles
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	33.3% 3/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	15.4% 2/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	37.1% 13/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	14.3% 5/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.2% 2/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.9% 8/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	16.7% 2/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	66.7% 6/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	23.1% 3/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	20.0% 7/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Blood and lymphatic system disorders Thrombocytopenia	66.7% 2/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	33.3% 4/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	55.6% 5/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	15.4% 2/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	54.3% 19/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Cardiac disorders Tachycardia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Ear and labyrinth disorders External ear pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Eye disorders Conjunctival haemorrhage	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Eye disorders Vision blurred	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Constipation	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	41.7% 5/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	15.4% 2/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.9% 8/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	33.3% 3/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.9% 8/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Flatulence	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Nausea	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	41.7% 5/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	33.3% 3/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	30.8% 4/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	34.3% 12/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Oral disorder	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Oral pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.2% 2/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Retching	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Vomiting	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	33.3% 4/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	33.3% 3/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	15.4% 2/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	31.4% 11/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Asthenia	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Chest pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Chills	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.4% 4/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Facial pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Fatigue	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	50.0% 6/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	14.3% 5/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Generalised oedema	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Malaise	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Mucosal haemorrhage	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Oedema	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Oedema peripheral	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Pyrexia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	15.4% 2/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	34.3% 12/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	25.7% 9/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Candida infection	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Influenza	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Otitis externa	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Pulmonary mycosis	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Sepsis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Septic shock	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Sinusitis fungal	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.4% 4/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Urinary tract infection	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Injury, poisoning and procedural complications Post lumbar puncture syndrome	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Activated partial thromboplastin time	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Alanine aminotransferase increased	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	17.1% 6/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	25.0% 3/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	55.6% 5/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	23.1% 3/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.9% 8/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	44.4% 4/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	20.0% 7/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Blood creatinine increased	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Blood test abnormal	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Gamma-glutamyltransferase increased	66.7% 2/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	55.6% 5/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Lipase increased	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Neutrophil count decreased	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Weight increased	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.2% 2/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	16.7% 2/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.2% 2/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	14.3% 5/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Hyperuricaemia	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.4% 4/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	17.1% 6/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.4% 4/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	17.1% 6/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	20.0% 7/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	15.4% 2/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.2% 2/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Dizziness	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Dysgeusia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Headache	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	16.7% 2/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.9% 8/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Nervous system disorder	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Paraesthesia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.2% 2/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Psychiatric disorders Anxiety	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.2% 2/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.4% 4/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Psychiatric disorders Insomnia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Renal and urinary disorders Urinary retention	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Reproductive system and breast disorders Testicular pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	25.7% 9/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.4% 4/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.2% 2/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	17.1% 6/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	22.2% 2/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.6% 3/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Skin and subcutaneous tissue disorders Rash erythematous	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Skin and subcutaneous tissue disorders Rash morbilliform	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Vascular disorders Hypertension	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	7.7% 1/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Vascular disorders Hypotension	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	14.3% 5/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Vascular disorders Phlebitis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	5.7% 2/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
General disorders Catheter site erythema	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Infections and infestations Sinusitis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Investigations Weight decreased	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	2.9% 1/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Nervous system disorders Tremor	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	8.3% 1/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.
Injury, poisoning and procedural complications Transplant failure	0.00% 0/3 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/12 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	11.1% 1/9 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/13 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.	0.00% 0/35 • AEs and SAEs were assessed from informed consent up to 28 calendar days after the last administration of investigational product, or up to the end of treatment visit (whichever is later) and to resolution/Grade 1 for treatment related AEs, up to 2 years. Events of veno-occlusive disease were reported up to 2 years after first dose of therapy. An event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& nonserious in another participant, or 1 participant may have experienced both a serious \& nonserious event.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI must remove any previously undisclosed Confidential Information (other than the Study results themselves) before public release.
Publication restrictions are in place

Restriction type: OTHER