Trial Outcomes & Findings for InO - A Retrospective Study of UK Patients With Leukaemia (NCT NCT04456959)

NCT ID: NCT04456959

Last Updated: 2022-09-28

Results Overview

In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported.

• Recruitment status: COMPLETED
• Target enrollment: 28 participants
• Primary outcome timeframe: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
• Results posted on: 2022-09-28

Participant Flow

Participants who initiated treatment with inotuzumab ozogamicin (InO) for relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), in real world settings as a part of routine clinical care, between June 2016 and January 2021, were included. Data of these participants, were retrieved from hospital records and observed in this retrospective, observational study for approximately 1 year duration.

Participant milestones

Measure	Inotuzumab Ozogamicin (InO) Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Age, Continuous	46.8 Years STANDARD_DEVIATION 19.7 • n=28 Participants
Sex: Female, Male Female	14 Participants n=28 Participants
Sex: Female, Male Male	14 Participants n=28 Participants
Time from ALL Diagnosis to Index Date	2.6 Years STANDARD_DEVIATION 5.3 • n=28 Participants
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0	5 Participants n=28 Participants
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) 1	4 Participants n=28 Participants
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) Not recorded	19 Participants n=28 Participants
Number of Participants According to Their Phase of Disease at Index Date First relapse	21 Participants n=28 Participants
Number of Participants According to Their Phase of Disease at Index Date Second relapse	6 Participants n=28 Participants
Number of Participants According to Their Phase of Disease at Index Date Third relapse	1 Participants n=28 Participants
Number of Participants According to Their Phase of Disease at Index Date Fourth or greater relapse	0 Participants n=28 Participants
Number of Participants According to Their Phase of Disease at Index Date CR	0 Participants n=28 Participants
Number of Participants According to History of Liver Disease Recorded for Prior to Index Date Period No	22 Participants n=28 Participants
Number of Participants According to History of Liver Disease Recorded for Prior to Index Date Period Not known	5 Participants n=28 Participants
Number of Participants According to History of Liver Disease Recorded for Prior to Index Date Period Yes	1 Participants n=28 Participants
Percentage of Positive Cell Blasts (CD22 expression test)	49.6 Percentage of cells STANDARD_DEVIATION 29.6 • n=8 Participants • Here number analyzed signifies participants evaluable for this baseline characteristic.
Number of Participants According to ALL Mutation Types (1;19)(q23;p13)	1 Participants n=28 Participants
Number of Participants According to ALL Mutation Types BCR-ABL	4 Participants n=28 Participants
Number of Participants According to ALL Mutation Types Complex karyotype	1 Participants n=28 Participants
Number of Participants According to ALL Mutation Types Cytogenetics failed	1 Participants n=28 Participants
Number of Participants According to ALL Mutation Types ETV6 Rearrangement	1 Participants n=28 Participants
Number of Participants According to ALL Mutation Types Gain 18 centromere	1 Participants n=28 Participants
Number of Participants According to ALL Mutation Types Gain part of chr 5	1 Participants n=28 Participants
Number of Participants According to ALL Mutation Types Not Known	16 Participants n=28 Participants
Number of Participants According to ALL Mutation Types Relapse with clonal evolution	1 Participants n=28 Participants
Number of Participants According to ALL Mutation Types t(8:14)	1 Participants n=28 Participants
Blood Platelet Counts	95.9 cells*10^9 per liter STANDARD_DEVIATION 76.2 • n=28 Participants
Blood Absolute Neutrophil Counts	4.1 cells*10^9 per liter STANDARD_DEVIATION 6.5 • n=18 Participants • Here number analyzed signifies participants evaluable for this baseline characteristic.
Blood Alanine Aminotransferase (ALT) Levels	37.9 International units per liter (IU/L) STANDARD_DEVIATION 35.3 • n=28 Participants
Blood Aspartate Aminotransferase (AST) Levels	29 International units per liter STANDARD_DEVIATION 2.8 • n=2 Participants • Here number analyzed signifies participants evaluable for this baseline characteristic.
Blood Bilirubin Levels	0.6 Milligrams per deciliter (mg/dL) STANDARD_DEVIATION 0.4 • n=25 Participants • Here number analyzed signifies participants evaluable for this baseline characteristic.
Blood Albumin Levels	3.6 Grams per deciliter (g/dL) STANDARD_DEVIATION 0.7 • n=28 Participants
Blood Gamma Glutamyl Transferase (GGT)	74.8 Units per liter (U/L) STANDARD_DEVIATION 82.7 • n=5 Participants • Here number analyzed signifies participants evaluable for this baseline characteristic.
Blood Alkaline Phosphatase (ALP) Levels	112.7 International units per liter STANDARD_DEVIATION 95.1 • n=27 Participants • Here number analyzed signifies participants evaluable for this characteristic.
Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period 1	21 Participants n=28 Participants
Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period 2	5 Participants n=28 Participants
Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period 3	1 Participants n=28 Participants
Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period Not known	1 Participants n=28 Participants

PRIMARY outcome

Timeframe: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline At least one line of prior chemotherapy recorded	27 Participants
Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline Not recorded	1 Participants

PRIMARY outcome

Timeframe: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants according to number of lines of salvage therapy anytime between initial diagnosis of ALL and InO initiation, were reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants According to Number of Lines of Salvage Therapy 1	6 Participants
Number of Participants According to Number of Lines of Salvage Therapy 2	1 Participants
Number of Participants According to Number of Lines of Salvage Therapy No salvage therapy	21 Participants

PRIMARY outcome

Timeframe: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.5 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) At least one line of prior HSCT recorded	10 Participants
Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) No prior HSCT	15 Participants
Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) Not recorded	3 Participants

PRIMARY outcome

Timeframe: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure who had at least 1 line of prior HSCT recorded.

In this outcome measure, number of participants were classified according to different type of conditioning regimen for each HSCT (high-dose intensity myeloablative, reduced-intensity/non-myeloablative), were reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=10 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants According to Type of Conditioning Regimen for Each HSCT High-dose intensity myeloablative	7 Participants
Number of Participants According to Type of Conditioning Regimen for Each HSCT Not known	1 Participants
Number of Participants According to Type of Conditioning Regimen for Each HSCT Reduced intensity/ non-myeloablative	2 Participants

PRIMARY outcome

Timeframe: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants who were previously treated with blinatumomab, were reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Were Treated Previously With Blinatumomab No prior treatment with Blinatumomab	24 Participants
Number of Participants Who Were Treated Previously With Blinatumomab Prior treatment with blinatumomab	4 Participants

PRIMARY outcome

Timeframe: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies Participants with prior CAR T-Cell therapy	0 Participants
Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies Participants with no prior CAR T-Cell therapy	18 Participants
Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies Not recorded	10 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, total duration of InO treatment was reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Total Duration of Treatment With Inotuzumab Ozogamicin	71.4 Days Standard Deviation 52.4

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants were classified according to total number of InO treatment cycles received.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles Received Total of 1 Cycle	6 Participants
Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles Received Total of 2 Cycles	13 Participants
Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles Received Total of 3 Cycles	5 Participants
Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles Received Total of 4 Cycles	2 Participants
Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles Received Total of 5 Cycles	0 Participants
Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles Received Total of 6 Cycles	2 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles 0 Cycle Interrupted	20 Participants
Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles 1 Cycle Interrupted	7 Participants
Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles 2 Cycle Interrupted	1 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies number of participants evaluable for specified rows.

In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle 1: Cycle was not Interrupted	24 Participants
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle1: Interrupted Due to Death	1 Participants
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle 1:Interrupted Due to Liver toxicity Treatment Related Adverse Events (TRAEs)	1 Participants
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle 1: Interrupted Due to Neutropenia and Severe Constipation	1 Participants
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle 1: Interrupted Due to SARS-CoV 2 infection	1 Participants
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle 2: Cycle was not Interrupted	19 Participants
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle 2: Interrupted Due to High Fever, Rigors, Vomiting, Hypotension	1 Participants
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle 2: Interrupted Due to Liver Toxicity TRAE(s)	1 Participants
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle 2: Interrupted Due to Nausea, Poor oral intake, Neutropenic Sepsis	1 Participants
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle 3: Cycle was not Interrupted	7 Participants
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle 3: Interrupted Due to Infection in Peripherally Inserted Central Catheter	1 Participants
Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption Cycle 3: Interrupted Due to Transferred to Another Hospital	1 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for specific rows.

In this outcome measure, number of participants according to prescribed starting InO dose, were reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 1: 0.8 milligram per meter square (mg/m^2)	1 Participants
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 1: 1.8 mg/m^2	27 Participants
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 2: 1.0 mg/m2	1 Participants
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 2: 1.2 mg/m^2	1 Participants
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 2: 1.5 mg/m^2	9 Participants
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 2: 1.8 mg/m^2	11 Participants
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 3: 1.5 mg/m^2	4 Participants
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 3: 1.8 mg/m^2	5 Participants
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 4: 0.5 mg/m^2	1 Participants
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 4: 1.5 mg/m^2	3 Participants
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 5: 1.5 mg/m^2	2 Participants
Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses Cycle 6: 1.5 mg/m^2	2 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, number analyzed signifies participants evaluable for specific rows.

In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 4 · Participants with no dose modification	3 Participants
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 4 · No data recorded	1 Participants
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 5 · Participants with no dose modification	2 Participants
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 5 · No data recorded	0 Participants
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 6 · Participants with no dose modification	2 Participants
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 6 · No data recorded	0 Participants
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 1 · Participants with no dose modification	26 Participants
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 1 · No data recorded	2 Participants
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 2 · Participants with no dose modification	20 Participants
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 2 · No data recorded	2 Participants
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 3 · Participants with no dose modification	7 Participants
Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose Cycle 3 · No data recorded	2 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy Not Treated With Concomitant Azole Antifungal Therapy	26 Participants
Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy Treated With Concomitant Azole Antifungal Therapy	2 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure and were treated with concomitant azole antifungal therapy.

In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=2 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Duration of Concomitant Azole Antifungal Therapy	20 Days Standard Deviation 1.4

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

CR was defined as documented in medical records or (if unavailable in the records) as less than (<) 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets greater than or equal to [>=] 100*10^9 cells per liter [/L] and absolute neutrophil counts [ANC] >=1*10^9 cells/L) and resolution of any extramedullary disease.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment	15 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

CRi was defined as documented in medical records or (if unavailable in the records) <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100* 10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment	5 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome, number of participants who achieved CR/CRi at the end of InO treatment are reported. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants With CR/CRi by the End of InO Treatment	20 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with CR/CRi.

CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=20 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Median Time to CR/CRi	1.7 Months Interval 1.6 to 4.3

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with CR/CRi.

Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising <1*10^-4 (<0.01%) of bone marrow nucleated cells. This outcome measure was analyzed in participants with CR/CRi. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=20 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi	14 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with negative MRD.

Negative MRD (among those who had CR/CRi) was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising <1*10^-4 (<0.01%) of bone marrow nucleated cells. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=14 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Achieved Negative MRD Classified Per InO Cycles 1	1 Participants
Number of Participants Who Achieved Negative MRD Classified Per InO Cycles 2	7 Participants
Number of Participants Who Achieved Negative MRD Classified Per InO Cycles 3 and above	6 Participants

SECONDARY outcome

Timeframe: At 3, 6, and 12 months post InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation 3 months	25 Participants
Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation 6 months	19 Participants
Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation 12 months	13 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants according to their cause of death were reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=19 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Classified According to Their Cause of Death Subarachnoid/Intraparenchymal Hemorrhage Stroke	1 Participants
Number of Participants Classified According to Their Cause of Death Acute Lymphoblastic Leukaemia	15 Participants
Number of Participants Classified According to Their Cause of Death Pneumonia	1 Participants
Number of Participants Classified According to Their Cause of Death SAR COV 2	1 Participants
Number of Participants Classified According to Their Cause of Death Veno-Occlusive Disease	1 Participants

SECONDARY outcome

Timeframe: InO initiation date to death due to any cause or last visit at time of data collection, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

OS was defined as the time from the index date to the date of death. Participants were censored at date of latest visit at the time of data collection. Kaplan-Meier method was used for OS analysis.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Overall Survival (OS)	11.7 Months Interval 6.3 to Upper limit of 95% CI could not be estimated because there were insufficient number of participants with event.

SECONDARY outcome

Timeframe: At 3, 6, and 12 months from InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

Relapse free survival: the time from the start of treatment to earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR: documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9/L and ANC >=1*10^9/L) and resolution of any extramedullary disease. CRi: documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9/L and ANC <1*10^9/L) and resolution of any extramedullary disease. Progressive disease (PD): a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation 3 months	82.1 Percentage of participants Interval 69.1 to 97.6
Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation 6 months	60.7 Percentage of participants Interval 45.1 to 81.8
Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation 12 months	39.3 Percentage of participants Interval 24.8 to 62.3

SECONDARY outcome

Timeframe: From InO initiation date to death or progressive disease, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

RFS was defined as the time from the start of treatment to earliest date of the following events: death, PD (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells /L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. PD: a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Relapse-free Survival (RFS)	8.86 Months Interval 4.93 to Upper limit of 95% CI was not estimable due insufficient number of participants with event.

SECONDARY outcome

Timeframe: Post InO treatment from date of follow up HSCT to death, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall number of Participants" signifies evaluable for this outcome measure.

NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=9 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Time to Non-relapse Mortality (NRM)	12.69 Months Interval 5.88 to Upper limit of 95% CI was not estimable due insufficient number of participants with event.

SECONDARY outcome

Timeframe: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants according to therapies they initiated post InO treatment were reported. One participant could have more than 1 type of therapies.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment Chemotherapy	16 Participants
Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment HSCT	9 Participants
Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment CAR-T cell therapy	8 Participants

SECONDARY outcome

Timeframe: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for each category.

CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. PD was defined as a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L. Stable disease was defined as increase of peripheral blasts with an absolute increase not >50%.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments HSCT: CR	5 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments HSCT: CRi	3 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments HSCT: Not Known	1 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments CAR-T cell therapy: CR	5 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments CAR-T cell therapy: CRi	1 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments CAR-T cell therapy: PD	1 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments CAR-T cell therapy: Not Known	2 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments Blinatumomab: CR	2 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments Blinatumomab: Not Recorded	2 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments Blinatumomab: PD	3 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments Blinatumomab: SD	1 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments Other Chemotherapy: CR	3 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments Other Chemotherapy: CRi	4 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments Other Chemotherapy: Missing	1 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments Other Chemotherapy: Not Recorded	11 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments Other Chemotherapy: PD	4 Participants
Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments Other Chemotherapy: SD	1 Participants

SECONDARY outcome

Timeframe: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants who survived at completion of InO treatment were reported.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=8 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Survived Post InO Blinatumomab Treatment	8 Participants

SECONDARY outcome

Timeframe: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment Participants Not With VOD/SOS	26 Participants
Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment Participants With VOD/SOS	2 Participants

SECONDARY outcome

Timeframe: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS.

VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=2 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Spironolactone	1 Participants
Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Ursodeoxycholic Acid	1 Participants

SECONDARY outcome

Timeframe: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS.

VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=2 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)	1 Participants

SECONDARY outcome

Timeframe: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.

VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=2 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants With Interrupted InO Treatment Due to VOD/SOS	2 Participants

SECONDARY outcome

Timeframe: Post InO Treatment, during data identification period from June 2016 to January 2021 (approximately 4.5 years); from the data collected and observed retrospectively over approximately 12 months of this study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS.

VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=2 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants With Moderate Severity VOD/SOS	2 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: Safety analysis set (SAS) included the medical records extracted for the purpose of the study from all eligible participants who were included in the study and had at least one dose of study medication.

Adverse event (AE) was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation Grade 3	1 Participants
Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation Grade 4	1 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with Grade 3 or 4 TRAE.

AE was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=2 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation Antibiotics/ Intensive Therapy Unit	1 Participants
Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation High dose septrin + Caspofungi	1 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=28 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation	1 Participants

SECONDARY outcome

Timeframe: Prior to post InO HSCT, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=5 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT	0 Participants

SECONDARY outcome

Timeframe: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study

Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for each category.

In this outcome measure, participants with significant risk factor for VOD/ SOS occurrence were reported. VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked

Outcome measures

Measure	Inotuzumab Ozogamicin (InO) n=9 Participants Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
Number of Participants With Significant Risk Factors for VOD/SOS Number of alkylating agents:1 · Experienced VOD/SOS: Yes	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Number of alkylating agents:1 · Experienced VOD/SOS: No	7 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Number of alkylating agents: 3 · Experienced VOD/SOS: Yes	0 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Number of alkylating agents: 3 · Experienced VOD/SOS: No	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Busulfan-containing regimen · Experienced VOD/SOS: Yes	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Busulfan-containing regimen · Experienced VOD/SOS: No	8 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last bilirubin concentration prior to follow-up HSCT: > upper limit normal (ULN) · Experienced VOD/SOS: Yes	0 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last bilirubin concentration prior to follow-up HSCT: > upper limit normal (ULN) · Experienced VOD/SOS: No	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last bilirubin concentration prior to follow-up HSCT: <ULN · Experienced VOD/SOS: Yes	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last bilirubin concentration prior to follow-up HSCT: <ULN · Experienced VOD/SOS: No	6 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last bilirubin concentration prior to follow-up HSCT: Missing · Experienced VOD/SOS: Yes	0 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last bilirubin concentration prior to follow-up HSCT: Missing · Experienced VOD/SOS: No	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Age: <55 years · Experienced VOD/SOS: Yes	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Age: <55 years · Experienced VOD/SOS: No	7 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Age: >55 years · Experienced VOD/SOS: Yes	0 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Age: >55 years · Experienced VOD/SOS: No	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last ALT concentration prior to follow-up HSCT: less than or equal to (≤)1.5 ULN · Experienced VOD/SOS: Yes	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last ALT concentration prior to follow-up HSCT: less than or equal to (≤)1.5 ULN · Experienced VOD/SOS: No	7 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last ALT concentration prior to follow-up HSCT: Missing · Experienced VOD/SOS: Yes	0 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last ALT concentration prior to follow-up HSCT: Missing · Experienced VOD/SOS: No	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last AST concentration prior to follow-up HSCT: ≤1.5 ULN · Experienced VOD/SOS: Yes	0 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last AST concentration prior to follow-up HSCT: ≤1.5 ULN · Experienced VOD/SOS: No	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last AST concentration prior to follow-up HSCT: Missing · Experienced VOD/SOS: Yes	1 Participants
Number of Participants With Significant Risk Factors for VOD/SOS Last AST concentration prior to follow-up HSCT: Missing · Experienced VOD/SOS: No	7 Participants

Adverse Events

Inotuzumab Ozogamicin (InO)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 19 deaths

Serious adverse events

Measure

Inotuzumab Ozogamicin (InO) n=28 participants at risk Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.

General disorders Lung

7.1% 2/28 • From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs were reported as per participants' medical records. There was no specific medical dictionary.

Other adverse events

Measure	Inotuzumab Ozogamicin (InO) n=28 participants at risk Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.
General disorders Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)	7.1% 2/28 • From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs were reported as per participants' medical records. There was no specific medical dictionary.
General disorders Liver	3.6% 1/28 • From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs were reported as per participants' medical records. There was no specific medical dictionary.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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 the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER