Trial Outcomes & Findings for Besponsa Post Marketing Surveillance Study (NCT NCT04307134)

Last Updated: 2025-12-31

Results Overview

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs included both SAEs and all non-SAEs. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event.

Recruitment status

COMPLETED

Target enrollment

108 participants

Primary outcome timeframe

From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Results posted on

2025-12-31

Participant Flow

Participants with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL) who were prescribed Inotuzumab Ozogamicin in real world setting as a routine clinical practice across South Korea were enrolled in this study.

Participant milestones

Participant milestones
Measure	Inotuzumab Ozogamicin Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Overall Study STARTED	108
Overall Study Enrolled	108
Overall Study Treated	107
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Inotuzumab Ozogamicin Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	3
Overall Study Other	3
Overall Study Death	21
Overall Study Enrolled but not Treated	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inotuzumab Ozogamicin n=107 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Age, Continuous	46.21 Years STANDARD_DEVIATION 16.58 • n=107 Participants
Sex: Female, Male Female	42 Participants n=107 Participants
Sex: Female, Male Male	65 Participants n=107 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Population: The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=107 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with AEs	99 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with SAEs	34 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Population: The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=107 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs) Participants with ADRs	53 Participants
Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs) Participants with SADRs	4 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Population: The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once.

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event. An AE was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all AEs were unexpected.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=107 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Unexpected AEs and SAEs Participants with unexpected AEs	85 Participants
Number of Participants With Unexpected AEs and SAEs Participants with unexpected SAEs	24 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Population: The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once.

An ADR was any untoward medical occurrence attributed to medicinal product in participant who had received that product. SADR was an ADR that resulted in any of the following: death; was life-threatening; required inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; or was important medical event. In this outcome measure, number of participants with unexpected ADRs and SADRs are reported. An ADR was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all ADRs were unexpected.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=107 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Unexpected ADRs and SADRs Participants with unexpected ADRs	15 Participants
Number of Participants With Unexpected ADRs and SADRs Participants with unexpected SADRs	1 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Population: The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure who had any AE and "Overall Number of Units Analyzed" signifies evaluable number of AEs.

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs' severity was graded using common terminology criteria for AEs (CTCAE) version 4.0; grade 1= mild AE; grade 2= moderate AE; grade 3= severe AE; grade 4= life-threatening AE and grade 5= death.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=845 Adverse Events Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of AEs According to Severity Grade 5 AEs	27 Adverse Events
Number of AEs According to Severity Grade 1 AEs	252 Adverse Events
Number of AEs According to Severity Grade 2 AEs	339 Adverse Events
Number of AEs According to Severity Grade 3 AEs	179 Adverse Events
Number of AEs According to Severity Grade 4 AEs	48 Adverse Events

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per action taken for AEs (withdrawn \[temporarily or permanently or delayed\]; dose reduced; dose increased; dose not changed; unknown, and not applicable) in this outcome measure. Not applicable per protocol referred to situations if participant died or if the treatment was completed prior to the reaction/event or if drug was not administered.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=845 Adverse Events Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of AEs According to Action Taken Withdrawn (temporarily or permanently or delayed)	46 Adverse Events
Number of AEs According to Action Taken Dose reduced	3 Adverse Events
Number of AEs According to Action Taken Dose increased	0 Adverse Events
Number of AEs According to Action Taken Dose not changed	319 Adverse Events
Number of AEs According to Action Taken Unknown	0 Adverse Events
Number of AEs According to Action Taken Not applicable	477 Adverse Events

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Population: The safety analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated with safety-related outcome measures at least once. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure who had any SAE and "Overall Number of Units Analyzed" signifies evaluable number of SAEs.

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per SAEs category (resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect and is an important medical event) in this outcome measure. One SAE could have more than 1 outcome/characteristic and have been counted in more than one category.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=60 Serious Adverse Events Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of AEs According to SAEs' Category SAEs that resulted in death	27 Serious Adverse Events
Number of AEs According to SAEs' Category SAEs that were life-threatening	9 Serious Adverse Events
Number of AEs According to SAEs' Category SAEs that required inpatient hospitalization or prolongation of hospitalization	45 Serious Adverse Events
Number of AEs According to SAEs' Category SAEs that resulted in persistent or significant disability/incapacity	1 Serious Adverse Events
Number of AEs According to SAEs' Category SAEs that resulted in congenital anomaly/birth defect	0 Serious Adverse Events
Number of AEs According to SAEs' Category SAEs that were considered as an important medical event	0 Serious Adverse Events

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per their outcomes (recovered, recovered with sequelae, recovering, not recovered, and unknown) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=845 Adverse Events Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of AEs According to Their Outcomes Recovered	593 Adverse Events
Number of AEs According to Their Outcomes Recovered with sequelae	0 Adverse Events
Number of AEs According to Their Outcomes Recovering	91 Adverse Events
Number of AEs According to Their Outcomes Not recovered	153 Adverse Events
Number of AEs According to Their Outcomes Unknown	8 Adverse Events

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

AE: any untoward medical occurrence in participant administered medicinal product. Number of AEs per causality of AE to study drug (certain, probable/likely, possible, unlikely, conditional/unclassified, and not-assessable/unclassifiable) were reported. Certain: couldn't be explained by other drugs, had clinically reasonable reaction on cessation of drug and pharmacological/phenomenological reaction to drug re-administration. Probable/likely: couldn't be explained by other drugs, had clinically reasonable reaction on drug cessation. Possible: could also be explained by other drugs, lacked information/unclear information on drug discontinuation. Unlikely: not likely to have causal relationship from drug administration, could also be explained by other drugs. Conditional/unclassified: needed more data to make appropriate assessment/additional of data being reviewed. Not-assessable: lacked sufficient information/conflicting information hampering accurate causality assessment.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=845 Adverse Events Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of AEs Based on Causality of AEs to the Study Drug Certain	10 Adverse Events
Number of AEs Based on Causality of AEs to the Study Drug Probable/likely	13 Adverse Events
Number of AEs Based on Causality of AEs to the Study Drug Possible	135 Adverse Events
Number of AEs Based on Causality of AEs to the Study Drug Unlikely	686 Adverse Events
Number of AEs Based on Causality of AEs to the Study Drug Conditional/unclassified	1 Adverse Events
Number of AEs Based on Causality of AEs to the Study Drug Not-assessable/unclassifiable	0 Adverse Events

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of AEs were classified as per other causality of AE to the study drug (disease under the study, other disease, concomitant treatment drug or non-drug, and others) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=686 Adverse Events Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of AEs Based on Other Causality of AEs Other disease	19 Adverse Events
Number of AEs Based on Other Causality of AEs Others	106 Adverse Events
Number of AEs Based on Other Causality of AEs Disease under the study	442 Adverse Events
Number of AEs Based on Other Causality of AEs Concomitant treatment drug or non-drug	119 Adverse Events

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of age (less than \[\<\] 65 years and more than or equal to \[\>=\] 65 years) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=99 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With AEs Classified According to Their Age at Baseline Participants With AEs who Aged <65 years at Baseline	82 Participants
Number of Participants With AEs Classified According to Their Age at Baseline Participants With AEs who aged >=65 years at Baseline	17 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of sex (female and male) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=99 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With AEs Classified According to Their Sex at Baseline Participants With AEs who were Female	39 Participants
Number of Participants With AEs Classified According to Their Sex at Baseline Participants With AEs who were Male	60 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of diagnosis (Philadelphia \[+\] B-cell Acute Lymphoblastic Leukemia \[ALL\], Philadelphia \[-\] B-cell ALL, and unknown) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=99 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With AEs Classified According to Their Diagnosis at Baseline Participants With AEs who had Philadelphia (+) B-cell ALL Diagnosis at Baseline	32 Participants
Number of Participants With AEs Classified According to Their Diagnosis at Baseline Participants With AEs who had Philadelphia (-) B-cell ALL Diagnosis at Baseline	67 Participants
Number of Participants With AEs Classified According to Their Diagnosis at Baseline Participants With AEs who had Unknown Diagnosis at Baseline	0 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Refractory Disease: failure to achieve complete response (CR) at the end of induction. Relapsed disease: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, absolute neutrophil count (ANC) \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. Number of participants with AEs were classified according to their baseline demographic characteristics of disease status (refractory, first relapsed, second relapsed and third or more relapsed) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=99 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With AEs Classified According to Their Disease Status at Baseline Participants With AEs who had Refractory Disease Status at Baseline	9 Participants
Number of Participants With AEs Classified According to Their Disease Status at Baseline Participants With AEs who had First Relapsed Disease Status at Baseline	54 Participants
Number of Participants With AEs Classified According to Their Disease Status at Baseline Participants With AEs who had Second Relapsed Disease Status at Baseline	28 Participants
Number of Participants With AEs Classified According to Their Disease Status at Baseline Participants With AEs who had Third or More Relapsed Disease Status at Baseline	8 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of renal disorder status (yes or no) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=99 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With AEs Classified According to Their Renal Disorder Status at Baseline Participants With AEs who had "Yes" for Renal Disorder at Baseline	7 Participants
Number of Participants With AEs Classified According to Their Renal Disorder Status at Baseline Participants With AEs who had "No" for Renal Disorder at Baseline	92 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of hepatic disorder status (yes or no) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=99 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With AEs Classified According to Their Hepatic Disorder Status at Baseline Participants With AEs who had "Yes" for Hepatic Disorder at Baseline	20 Participants
Number of Participants With AEs Classified According to Their Hepatic Disorder Status at Baseline Participants With AEs who had "No" for Hepatic Disorder at Baseline	79 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of allergic history (yes or no) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=99 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With AEs Classified According to Their Allergic History Status at Baseline Participants With AEs who had "Yes" for Allergic history at Baseline	49 Participants
Number of Participants With AEs Classified According to Their Allergic History Status at Baseline Participants With AEs who had "No" for Allergic history at Baseline	50 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. VOD also known as SOS is a potentially life-threatening condition in which the small veins in the liver are blocked. This obstruction impairs blood flow through the liver and can lead to liver damage and failure. Number of participants with AEs were classified according to their baseline demographic characteristics of VOD/SOS (yes or no) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=99 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With AEs Classified According to Their Veno-occlusive Liver Disease/ Sinusoidal Obstruction Syndrome (VOD /SOS) Status at Baseline Participants With AEs who had "Yes" for VOD/SOS status at Baseline	0 Participants
Number of Participants With AEs Classified According to Their Veno-occlusive Liver Disease/ Sinusoidal Obstruction Syndrome (VOD /SOS) Status at Baseline Participants With AEs who had "No" for VOD/SOS status at Baseline	99 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of previous systemic therapy status (yes, no, and unknown) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=99 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With AEs Classified According to Their Previous Systemic Therapy Status at Baseline Participants With AEs who had "Unknown" for Previous Systemic Therapy at Baseline	0 Participants
Number of Participants With AEs Classified According to Their Previous Systemic Therapy Status at Baseline Participants With AEs who had "Yes" for Previous Systemic Therapy at Baseline	99 Participants
Number of Participants With AEs Classified According to Their Previous Systemic Therapy Status at Baseline Participants With AEs who had "No" for Previous Systemic Therapy at Baseline	0 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of previous hematopoietic cell transplant status (yes, no, and unknown) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=99 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With AEs Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline Participants With AEs who had "Yes" for Previous Hematopoietic Cell Transplant at Baseline	53 Participants
Number of Participants With AEs Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline Participants With AEs who had "No" for Previous Hematopoietic Cell Transplant at Baseline	46 Participants
Number of Participants With AEs Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline Participants With AEs who had "Unknown" for Previous Hematopoietic Cell Transplant at Baseline	0 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to the end of study (maximum up to 311 days)

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to the use of concomitant medications (yes and no) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=99 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With AEs Classified According to Usage of Concomitant Medication Throughout the Study Participants with AEs who took Concomitant Medication	99 Participants
Number of Participants With AEs Classified According to Usage of Concomitant Medication Throughout the Study Participants with AEs who did not take Concomitant Medication	0 Participants

PRIMARY outcome

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

An ADR was any untoward medical occurrence attributed to a medicinal product in a participant who had received that product. In this outcome measure, number of elderly participants (\>=65 years) with ADRs at baseline were reported.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=17 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Elderly Participants With ADRs	10 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

Population: The effectiveness analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated based upon effectiveness outcome measures.

BOR was defined as the best response recorded from the start of treatment until disease progression (PD) or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. Ineffectiveness was defined as BOR of refractory disease, PD, or relapsed disease. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, ANC \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. Refractory Disease: failure to achieve CR at the end of induction. Relapsed disease: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=94 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Best Overall Response (BOR) Effective	74 Participants
Number of Participants With Best Overall Response (BOR) Ineffective	20 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

Population: The effectiveness analysis set included participants who have been administered Inotuzumab Ozogamicin at least once and evaluated based upon effectiveness outcome measures. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with effective BOR.

BOR was defined as the best response recorded from the start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, ANC \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of age (\<65 years and \>=65 years) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=74 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Effective BOR Classified According to Their Age at Baseline Participants with Effective BOR who Aged <65 years at Baseline	59 Participants
Number of Participants With Effective BOR Classified According to Their Age at Baseline Participants with Effective BOR who Aged >=65 years at Baseline	15 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=74 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Effective BOR Classified According to Sex at Baseline Participants With Effective BOR who were Female	32 Participants
Number of Participants With Effective BOR Classified According to Sex at Baseline Participants With Effective BOR who were Male	42 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

BOR was defined as the best response recorded from the start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, ANC \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of diagnosis (Philadelphia \[+\] B-cell ALL, Philadelphia \[-\] B-cell ALL and unknown) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=74 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Effective BOR Classified According to Their Diagnosis at Baseline Participants With Effective BOR who had Philadelphia (+) B-cell ALL Diagnosis at Baseline	22 Participants
Number of Participants With Effective BOR Classified According to Their Diagnosis at Baseline Participants With Effective BOR who had Philadelphia (-) B-cell ALL Diagnosis at Baseline	52 Participants
Number of Participants With Effective BOR Classified According to Their Diagnosis at Baseline Participants With Effective BOR who had Unknown Diagnosis at Baseline	0 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, ANC \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. Refractory Disease: failure to achieve CR at the end of induction. Relapsed disease: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR. The number of participants with effective BOR were classified according to their baseline demographic characteristic of disease status (refractory, first relapsed, second relapsed and third or more relapsed) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=74 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Effective BOR Classified According to Their Disease Status at Baseline Participants With Effective BOR who had Refractory Disease Status at Baseline	8 Participants
Number of Participants With Effective BOR Classified According to Their Disease Status at Baseline Participants With Effective BOR who had First Relapsed Disease Status at Baseline	40 Participants
Number of Participants With Effective BOR Classified According to Their Disease Status at Baseline Participants With Effective BOR who had Second Relapsed Disease Status at Baseline	21 Participants
Number of Participants With Effective BOR Classified According to Their Disease Status at Baseline Participants With Effective BOR who had Third or More Relapsed Disease Status at Baseline	5 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, ANC \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of renal disorder (yes and no) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=74 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Effective BOR Classified According to Their Renal Disorder at Baseline Participants With Effective BOR who had Renal Disorder as "Yes" at Baseline	4 Participants
Number of Participants With Effective BOR Classified According to Their Renal Disorder at Baseline Participants With Effective BOR who had Renal Disorder as "No" at Baseline	70 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, ANC \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of hepatic disorder (yes and no) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=74 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Effective BOR Classified According to Their Hepatic Disorder at Baseline Participants With Effective BOR who had Hepatic Disorder as "Yes" at Baseline	17 Participants
Number of Participants With Effective BOR Classified According to Their Hepatic Disorder at Baseline Participants With Effective BOR who had Hepatic Disorder as "No" at Baseline	57 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, ANC \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of allergic history (yes and no) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=74 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Effective BOR Classified According to Their Allergic History at Baseline Participants With Effective BOR who had Allergic History as "Yes" at Baseline	32 Participants
Number of Participants With Effective BOR Classified According to Their Allergic History at Baseline Participants With Effective BOR who had Allergic History as "No" at Baseline	42 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, ANC \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. VOD also known as SOS is a potentially life-threatening condition in which the small veins in the liver are blocked. This obstruction impairs blood flow through the liver and can lead to liver damage and failure. The number of participants with effective BOR were classified according to their baseline demographic characteristic of VOD/SOS (yes and no) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=74 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Effective BOR Classified According to Their VOD/SOS Status at Baseline Participants With Effective BOR who had VOD/SOS Status as "Yes" at Baseline	0 Participants
Number of Participants With Effective BOR Classified According to Their VOD/SOS Status at Baseline Participants With Effective BOR who had VOD/SOS Status as "No" at Baseline	74 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, ANC \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of previous systemic therapy (yes, no and unknown) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=74 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Effective BOR Classified According to Their Previous Systemic Therapy Status at Baseline Participants With Effective BOR who had Previous Systemic Therapy as "Yes" at Baseline	74 Participants
Number of Participants With Effective BOR Classified According to Their Previous Systemic Therapy Status at Baseline Participants With Effective BOR who had Previous Systemic Therapy as "No" at Baseline	0 Participants
Number of Participants With Effective BOR Classified According to Their Previous Systemic Therapy Status at Baseline Participants With Effective BOR who had Previous Systemic Therapy as "Unknown" at Baseline	0 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, ANC \>1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of previous hematopoietic cell transplant (yes, no and unknown) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=74 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Effective BOR Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline Participants With Effective BOR who had Previous Hematopoietic Cell Transplant as "Yes" at Baseline	36 Participants
Number of Participants With Effective BOR Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline Participants With Effective BOR who had Previous Hematopoietic Cell Transplant as "No" at Baseline	38 Participants
Number of Participants With Effective BOR Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline Participants With Effective BOR who had Previous Hematopoietic Cell Transplant "Unknown" at Baseline	0 Participants

SECONDARY outcome

Timeframe: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, ANC \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to usage of concomitant medication (yes and no) in this outcome measure.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin n=74 Participants Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Number of Participants With Effective BOR Classified According to Usage of Concomitant Medication Throughout the Study Participants With Effective BOR who Took Concomitant Medication	74 Participants
Number of Participants With Effective BOR Classified According to Usage of Concomitant Medication Throughout the Study Participants With Effective BOR who did not Take Concomitant Medication	0 Participants

Adverse Events

Inotuzumab Ozogamicin

Serious events: 34 serious events

Other events: 97 other events

Deaths: 24 deaths

Serious adverse events

Serious adverse events
Measure	Inotuzumab Ozogamicin n=107 participants at risk Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Blood and lymphatic system disorders Cytopenia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Cardiac disorders Myocardial ischaemia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Nausea	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Necrotising colitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Stomatitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Vomiting	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Hepatobiliary disorders Hepatic failure	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Acute graft versus host disease in intestine	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Acute graft versus host disease	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Acute graft versus host disease in liver	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Chronic graft versus host disease oral	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Graft versus host disease in gastrointestinal tract	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Graft versus host disease in lung	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Septic shock	6.5% 7/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Pneumonia	4.7% 5/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Pyelonephritis acute	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Bacteraemia	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Cellulitis	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Enterococcal bacteraemia	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Bacterial infection	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Bronchopulmonary aspergillosis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Device related infection	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Endocarditis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations External ear cellulitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Pneumocystis jirovecii pneumonia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Sepsis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Urinary tract infection	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Tumour lysis syndrome	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	6.5% 7/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Cerebral infarction	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Haemorrhage intracranial	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Neuropathy peripheral	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Renal and urinary disorders Haematuria	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Bronchiolitis obliterans syndrome	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Rash	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Vascular disorders Venoocclusive disease	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.

Other adverse events

Other adverse events
Measure	Inotuzumab Ozogamicin n=107 participants at risk Participants who were treated with Inotuzumab Ozogamicin as a part of routine clinical practice were included in this observational study. No intervention was administered under this study.
Blood and lymphatic system disorders Neutropenia	27.1% 29/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Blood and lymphatic system disorders Febrile neutropenia	26.2% 28/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Blood and lymphatic system disorders Anaemia	17.8% 19/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Blood and lymphatic system disorders Cytopenia	10.3% 11/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Blood and lymphatic system disorders Thrombocytopenia	9.3% 10/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Blood and lymphatic system disorders Lymphopenia	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Blood and lymphatic system disorders Thrombotic microangiopathy	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Blood and lymphatic system disorders Bicytopenia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Blood and lymphatic system disorders Eosinophilia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Blood and lymphatic system disorders Iron deficiency anaemia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Cardiac disorders Atrial fibrillation	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Cardiac disorders Cardiac failure	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Ear and labyrinth disorders Deafness	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Ear and labyrinth disorders Ear discomfort	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Endocrine disorders Hyperthyroidism	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Endocrine disorders Hypothyroidism	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Eye disorders Dry eye	3.7% 4/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Eye disorders Blepharitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Eye disorders Chalazion	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Eye disorders Keratitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Eye disorders Retinal exudates	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Eye disorders Retinal haemorrhage	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Eye disorders Vision blurred	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Eye disorders Vitreous floaters	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Nausea	22.4% 24/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Diarrhoea	17.8% 19/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Stomatitis	15.0% 16/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Dyspepsia	8.4% 9/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Vomiting	5.6% 6/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Abdominal pain	5.6% 6/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Abdominal discomfort	4.7% 5/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Constipation	4.7% 5/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Haemorrhoids	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Proctalgia	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Oral pain	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Enterocolitis	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Abdominal pain upper	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Anal fissure	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Dry mouth	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Gastric haemorrhage	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Hiatus hernia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Ileus	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Mouth ulceration	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Oral mucosa haematoma	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Periodontal disease	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Pulpless tooth	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Gastrointestinal disorders Tooth impacted	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
General disorders Pyrexia	27.1% 29/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
General disorders Pain	4.7% 5/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
General disorders Oedema	3.7% 4/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
General disorders Chest pain	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
General disorders Chills	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
General disorders Influenza like illness	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
General disorders Asthenia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
General disorders Face oedema	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
General disorders Generalised oedema	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
General disorders Localised oedema	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
General disorders Oedema peripheral	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Hepatobiliary disorders Cholestatic liver injury	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Hepatobiliary disorders Hyperbilirubinaemia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Hepatobiliary disorders Venoocclusive liver disease	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Acute graft versus host disease in skin	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Acute graft versus host disease	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Graft versus host disease in gastrointestinal tract	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Engraftment syndrome	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Graft versus host disease in lung	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Immune system disorders Graft versus host disease oral	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations COVID-19	9.3% 10/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Bacteraemia	7.5% 8/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Cytomegalovirus viraemia	3.7% 4/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Clostridium difficile colitis	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Folliculitis	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Herpes zoster	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Pneumonia	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Staphylococcal bacteraemia	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Urinary tract infection	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Bronchopulmonary aspergillosis	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Cytomegalovirus infection	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Pneumonia fungal	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Pneumonia parainfluenzae viral	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Rhinitis	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Sinusitis	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Pneumonia klebsiella	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Anal abscess	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Atypical pneumonia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Bacteriuria	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Bronchiolitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Clostridium difficile infection	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Conjunctivitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Endocarditis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Herpes dermatitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Herpes simplex	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Large intestine infection	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Meningitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Oral candidiasis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Oral herpes	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Otitis externa	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Otitis media chronic	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Parainfluenzae virus infection	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Pathogen resistance	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Periodontitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Pharyngitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Pneumonia pneumococcal	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Pulpitis dental	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Sepsis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Tinea pedis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Infections and infestations Tonsillitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Injury, poisoning and procedural complications Allergic transfusion reaction	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Injury, poisoning and procedural complications Sunburn	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Injury, poisoning and procedural complications Urethral injury	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Platelet count decreased	25.2% 27/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Liver function test increased	22.4% 24/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Neutrophil count decreased	8.4% 9/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Aspartate aminotransferase increased	4.7% 5/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Blast cells present	4.7% 5/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Blast cell count increased	3.7% 4/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Weight increased	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Alanine aminotransferase increased	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Blood lactate dehydrogenase increased	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations C-reactive protein increased	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Weight decreased	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Blood alkaline phosphatase increased	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Blood bilirubin increased	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Coagulation test abnormal	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Gamma-glutamyltransferase increased	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations International normalised ratio increased	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations Lymphocyte count decreased	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Investigations White blood cell count decreased	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Hypokalaemia	12.1% 13/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Decreased appetite	8.4% 9/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Hypomagnesaemia	5.6% 6/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Hypophosphataemia	5.6% 6/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Electrolyte imbalance	3.7% 4/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Hyperkalaemia	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Tumour lysis syndrome	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Hyperphosphataemia	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Hyperglycaemia	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Hyperuricaemia	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Fluid retention	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Glucose tolerance impaired	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Hypoalbuminaemia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Metabolism and nutrition disorders Hyponatraemia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Myalgia	5.6% 6/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 4/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Back pain	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Bone pain	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Bursitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Chest wall mass	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Groin pain	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia recurrent	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia recurrent	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemic retinopathy	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Headache	7.5% 8/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Dizziness	3.7% 4/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Seizure	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Facial paralysis	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Neuralgia	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Neuropathy peripheral	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Hydrocephalus	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Hypoaesthesia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Paraesthesia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Nervous system disorders Somnolence	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Psychiatric disorders Insomnia	3.7% 4/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Psychiatric disorders Anxiety	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Psychiatric disorders Depression	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Psychiatric disorders Adjustment disorder with depressed mood	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Psychiatric disorders Delirium	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Psychiatric disorders Depressed mood	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Renal and urinary disorders Acute kidney injury	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Renal and urinary disorders Pollakiuria	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Reproductive system and breast disorders Pelvic pain	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Reproductive system and breast disorders Scrotal swelling	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.6% 6/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.7% 5/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.7% 4/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Cough	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Productive cough	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Respiratory symptom	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Asthma	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Hiccups	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Obliterative bronchiolitis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Rash	9.3% 10/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Pruritus	4.7% 5/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Urticaria	3.7% 4/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Decubitus ulcer	1.9% 2/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Blister	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Dermatitis contact	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Eczema	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Rash follicular	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Skin lesion	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Skin and subcutaneous tissue disorders Skin necrosis	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Surgical and medical procedures Tooth extraction	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Vascular disorders Hypotension	3.7% 4/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Vascular disorders Hypertension	2.8% 3/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.
Vascular disorders Venoocclusive disease	0.93% 1/107 • From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. The safety analysis set included participants who had been administered Inotuzumab ozogamicin at least once and evaluated with safety-related outcome measures at least once.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER