InO - A Retrospective Study of UK Patients With Leukaemia

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04456959
• Collaborator: (none)
• Enrollment: 28
• Locations: 4
• Actual Duration (Months): 12.7
• Patients Per Site: 7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to describe the demographics and clinical characteristics, treatment pathway, and effectiveness and safety of inotuzumab ozogamicin in patients with relapsed/refractory B-cell acute lymphoblastic leukaemia treated with inotuzumab ozogamicin in the real-world.

Condition or Disease	Intervention/Treatment	Phase
Precursor Cell Lymphoblastic Leukemia-Lymphoma	Drug: Inotuzumab Ozogamicin

Study Design

• Study Type: Observational
• Actual Enrollment: 28 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective Chart Review of UK Patients With Relapsed/Refractory Acute Lymphoblastic Leukaemia Treated With Inotuzumab Ozogamicin, a Real World Research Study
• Actual Study Start Date: Jan 6, 2020
• Actual Primary Completion Date: Jan 27, 2021
• Actual Study Completion Date: Jan 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Adult R/R ALL patients who have received InO Relapsed/refractory ALL patients who are 18 years and over and initiated InO between 1st of June 2016 and date of data collection (to be confirmed). They will have accessed InO treatment via NHS commissioning, via the CUP, or via private purchase and will have at least 3 months follow up from the index date unless death occurs within that time.	Drug: Inotuzumab Ozogamicin; Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.; Other Names: CMC-544

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline [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]

   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.

2. Number of Participants According to Number of Lines of Salvage Therapy [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]

   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.

3. Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) [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]

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

4. Number of Participants According to Type of Conditioning Regimen for Each HSCT [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]

   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.

5. Number of Participants Who Were Treated Previously With Blinatumomab [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]

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

6. Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies [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]

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

Secondary Outcome Measures

1. Total Duration of Treatment With Inotuzumab Ozogamicin [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]

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

2. Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles [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]

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

3. Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles [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]

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

4. Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption [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]

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

5. Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses [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]

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

6. Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose [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]

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

7. Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy [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]

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

8. Duration of Concomitant Azole Antifungal Therapy [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]

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

9. Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment [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]

   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.

10. Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment [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]

    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.

11. Number of Participants With CR/CRi by the End of InO Treatment [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]

    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.

12. Median Time to CR/CRi [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]

    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.

13. Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi [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]

    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.

14. Number of Participants Who Achieved Negative MRD Classified Per InO Cycles [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]

    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.

15. Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation [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]

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

16. Number of Participants Classified According to Their Cause of Death [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]

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

17. Overall Survival (OS) [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]

    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.

18. Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation [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]

    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.

19. Relapse-free Survival (RFS) [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]

    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.

20. Time to Non-relapse Mortality (NRM) [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]

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

21. Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment [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]

    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.

22. Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments [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]

    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%.

23. Number of Participants Who Survived Post InO Blinatumomab Treatment [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]

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

24. Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment [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]

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

25. Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) [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]

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

26. Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) [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]

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

27. Number of Participants With Interrupted InO Treatment Due to VOD/SOS [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]

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

28. Number of Participants With Moderate Severity VOD/SOS [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]

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

29. Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation [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]

    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.

30. Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation [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]

    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.

31. Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation [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]

32. Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT [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]

33. Number of Participants With Significant Risk Factors for VOD/SOS [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]

    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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with relapsed/refractory ALL.

• Patients who initiated InO between 1st of June 2016 and date of data collection.

• Patients who accessed InO treatment via NHS commissioning, via the CUP, or via private purchase.

• Patient aged ≥18 years old at initiation of InO treatment

Exclusion Criteria:

• Patients initiated on treatment with InO at a different hospital than the ones selected in this study.

• Patients with <3 months of follow-up since index date, unless death occurs <3 months from index date.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Bristol NHS Foundation Trust	Bristol		United Kingdom	BS1 3NU
2	University College London Hospital NHS Foundation Trust	London		United Kingdom	NW1 2PG
3	The Royal Marsden NHS Foundation Trust of Fulham Road	London		United Kingdom	SW3 6JJ
4	Taunton and Somerset NHS Foundation Trust of Musgrove Park Hospital	Taunton		United Kingdom	TA1 5DA

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Jul 18, 2019
• Statistical Analysis Plan - Jun 16, 2020

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04456959
• Other Study ID Numbers: X9001222
• First Posted: Jul 7, 2020
• Last Update Posted: Mar 31, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Inotuzumab Ozogamicin

Study Results

Participant Flow

Recruitment Details

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	28
COMPLETED	28
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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 Participants	28
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	46.8 (19.7)
Sex: Female, Male (Count of Participants)
Female	14 50%
Male	14 50%
Race and Ethnicity Not Collected (Count of Participants)
Time from ALL Diagnosis to Index Date (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	2.6 (5.3)
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) (Count of Participants)
0	5 17.9%
1	4 14.3%
Not recorded	19 67.9%
Number of Participants According to Their Phase of Disease at Index Date (Count of Participants)
First relapse	21 75%
Second relapse	6 21.4%
Third relapse	1 3.6%
Fourth or greater relapse	0 0%
CR	0 0%
Number of Participants According to History of Liver Disease Recorded for Prior to Index Date Period (Count of Participants)
No	22 78.6%
Not known	5 17.9%
Yes	1 3.6%
Percentage of Positive Cell Blasts (CD22 expression test) (Percentage of cells) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of cells]	49.6 (29.6)
Number of Participants According to ALL Mutation Types (Count of Participants)
(1;19)(q23;p13)	1 3.6%
BCR-ABL	4 14.3%
Complex karyotype	1 3.6%
Cytogenetics failed	1 3.6%
ETV6 Rearrangement	1 3.6%
Gain 18 centromere	1 3.6%
Gain part of chr 5	1 3.6%
Not Known	16 57.1%
Relapse with clonal evolution	1 3.6%
t(8:14)	1 3.6%
Blood Platelet Counts (cells*10^9 per liter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells*10^9 per liter]	95.9 (76.2)
Blood Absolute Neutrophil Counts (cells*10^9 per liter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells*10^9 per liter]	4.1 (6.5)
Blood Alanine Aminotransferase (ALT) Levels (International units per liter (IU/L)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [International units per liter (IU/L)]	37.9 (35.3)
Blood Aspartate Aminotransferase (AST) Levels (International units per liter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [International units per liter]	29 (2.8)
Blood Bilirubin Levels (Milligrams per deciliter (mg/dL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Milligrams per deciliter (mg/dL)]	0.6 (0.4)
Blood Albumin Levels (Grams per deciliter (g/dL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Grams per deciliter (g/dL)]	3.6 (0.7)
Blood Gamma Glutamyl Transferase (GGT) (Units per liter (U/L)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units per liter (U/L)]	74.8 (82.7)
Blood Alkaline Phosphatase (ALP) Levels (International units per liter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [International units per liter]	112.7 (95.1)
Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period (Count of Participants)
1	21 75%
2	5 17.9%
3	1 3.6%
Not known	1 3.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
At least one line of prior chemotherapy recorded	27 96.4%
Not recorded	1 3.6%

2. Primary Outcome

Title	Number of Participants According to Number of Lines of Salvage Therapy
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
1	6 21.4%
2	1 3.6%
No salvage therapy	21 75%

3. Primary Outcome

Title	Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT)
Description	In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
At least one line of prior HSCT recorded	10 35.7%
No prior HSCT	15 53.6%
Not recorded	3 10.7%

4. Primary Outcome

Title	Number of Participants According to Type of Conditioning Regimen for Each HSCT
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	10
High-dose intensity myeloablative	7 25%
Not known	1 3.6%
Reduced intensity/ non-myeloablative	2 7.1%

5. Primary Outcome

Title	Number of Participants Who Were Treated Previously With Blinatumomab
Description	In this outcome measure, number of participants who were previously treated with blinatumomab, were reported.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Prior treatment with blinatumomab	4 14.3%
No prior treatment with Blinatumomab	24 85.7%

6. Primary Outcome

Title	Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies
Description	In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Participants with prior CAR T-Cell therapy	0 0%
Participants with no prior CAR T-Cell therapy	18 64.3%
Not recorded	10 35.7%

7. Secondary Outcome

Title	Total Duration of Treatment With Inotuzumab Ozogamicin
Description	In this outcome measure, total duration of InO treatment was reported.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Mean (Standard Deviation) [Days]	71.4 (52.4)

8. Secondary Outcome

Title	Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles
Description	In this outcome measure, number of participants were classified according to total number of InO treatment cycles received.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Received Total of 1 Cycle	6 21.4%
Received Total of 2 Cycles	13 46.4%
Received Total of 3 Cycles	5 17.9%
Received Total of 4 Cycles	2 7.1%
Received Total of 5 Cycles	0 0%
Received Total of 6 Cycles	2 7.1%

9. Secondary Outcome

Title	Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles
Description	In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
0 Cycle Interrupted	20 71.4%
1 Cycle Interrupted	7 25%
2 Cycle Interrupted	1 3.6%

10. Secondary Outcome

Title	Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption
Description	In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Cycle 1: Cycle was not Interrupted	24 85.7%
Cycle1: Interrupted Due to Death	1 3.6%
Cycle 1:Interrupted Due to Liver toxicity Treatment Related Adverse Events (TRAEs)	1 3.6%
Cycle 1: Interrupted Due to Neutropenia and Severe Constipation	1 3.6%
Cycle 1: Interrupted Due to SARS-CoV 2 infection	1 3.6%
Cycle 2: Cycle was not Interrupted	19 67.9%
Cycle 2: Interrupted Due to High Fever, Rigors, Vomiting, Hypotension	1 3.6%
Cycle 2: Interrupted Due to Liver Toxicity TRAE(s)	1 3.6%
Cycle 2: Interrupted Due to Nausea, Poor oral intake, Neutropenic Sepsis	1 3.6%
Cycle 3: Cycle was not Interrupted	7 25%
Cycle 3: Interrupted Due to Infection in Peripherally Inserted Central Catheter	1 3.6%
Cycle 3: Interrupted Due to Transferred to Another Hospital	1 3.6%

11. Secondary Outcome

Title	Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses
Description	In this outcome measure, number of participants according to prescribed starting InO dose, were reported.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Cycle 1: 0.8 milligram per meter square (mg/m^2)	1 3.6%
Cycle 1: 1.8 mg/m^2	27 96.4%
Cycle 2: 1.0 mg/m2	1 3.6%
Cycle 2: 1.2 mg/m^2	1 3.6%
Cycle 2: 1.5 mg/m^2	9 32.1%
Cycle 2: 1.8 mg/m^2	11 39.3%
Cycle 3: 1.5 mg/m^2	4 14.3%
Cycle 3: 1.8 mg/m^2	5 17.9%
Cycle 4: 0.5 mg/m^2	1 3.6%
Cycle 4: 1.5 mg/m^2	3 10.7%
Cycle 5: 1.5 mg/m^2	2 7.1%
Cycle 6: 1.5 mg/m^2	2 7.1%

12. Secondary Outcome

Title	Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose
Description	In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Participants with no dose modification	26 92.9%
No data recorded	2 7.1%
Participants with no dose modification	20 71.4%
No data recorded	2 7.1%
Participants with no dose modification	7 25%
No data recorded	2 7.1%
Participants with no dose modification	3 10.7%
No data recorded	1 3.6%
Participants with no dose modification	2 7.1%
No data recorded	0 0%
Participants with no dose modification	2 7.1%
No data recorded	0 0%

13. Secondary Outcome

Title	Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy
Description	In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Not Treated With Concomitant Azole Antifungal Therapy	26 92.9%
Treated With Concomitant Azole Antifungal Therapy	2 7.1%

14. Secondary Outcome

Title	Duration of Concomitant Azole Antifungal Therapy
Description	In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	2
Mean (Standard Deviation) [Days]	20 (1.4)

15. Secondary Outcome

Title	Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Count of Participants [Participants]	15 53.6%

16. Secondary Outcome

Title	Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Count of Participants [Participants]	5 17.9%

17. Secondary Outcome

Title	Number of Participants With CR/CRi by the End of InO Treatment
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Count of Participants [Participants]	20 71.4%

18. Secondary Outcome

Title	Median Time to CR/CRi
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	20
Median (95% Confidence Interval) [Months]	1.7

19. Secondary Outcome

Title	Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	20
Count of Participants [Participants]	14 50%

20. Secondary Outcome

Title	Number of Participants Who Achieved Negative MRD Classified Per InO Cycles
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	14
1	1 3.6%
2	7 25%
3 and above	6 21.4%

21. Secondary Outcome

Title	Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation
Description	In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
3 months	25 89.3%
6 months	19 67.9%
12 months	13 46.4%

22. Secondary Outcome

Title	Number of Participants Classified According to Their Cause of Death
Description	In this outcome measure, number of participants according to their cause of death were reported.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	19
Acute Lymphoblastic Leukaemia	15 53.6%
Pneumonia	1 3.6%
SAR COV 2	1 3.6%
Subarachnoid/Intraparenchymal Hemorrhage Stroke	1 3.6%
Veno-Occlusive Disease	1 3.6%

23. Secondary Outcome

Title	Overall Survival (OS)
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Median (95% Confidence Interval) [Months]	11.7

24. Secondary Outcome

Title	Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
3 months	82.1 293.2%
6 months	60.7 216.8%
12 months	39.3 140.4%

25. Secondary Outcome

Title	Relapse-free Survival (RFS)
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Median (95% Confidence Interval) [Months]	8.86

26. Secondary Outcome

Title	Time to Non-relapse Mortality (NRM)
Description	NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	9
Median (95% Confidence Interval) [Months]	12.69

27. Secondary Outcome

Title	Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Chemotherapy	16 57.1%
HSCT	9 32.1%
CAR-T cell therapy	8 28.6%

28. Secondary Outcome

Title	Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments
Description	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%.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
HSCT: CR	5 17.9%
HSCT: CRi	3 10.7%
HSCT: Not Known	1 3.6%
CAR-T cell therapy: CR	5 17.9%
CAR-T cell therapy: CRi	1 3.6%
CAR-T cell therapy: PD	1 3.6%
CAR-T cell therapy: Not Known	2 7.1%
Blinatumomab: CR	2 7.1%
Blinatumomab: Not Recorded	2 7.1%
Blinatumomab: PD	3 10.7%
Blinatumomab: SD	1 3.6%
Other Chemotherapy: CR	3 10.7%
Other Chemotherapy: CRi	4 14.3%
Other Chemotherapy: Missing	1 3.6%
Other Chemotherapy: Not Recorded	11 39.3%
Other Chemotherapy: PD	4 14.3%
Other Chemotherapy: SD	1 3.6%

29. Secondary Outcome

Title	Number of Participants Who Survived Post InO Blinatumomab Treatment
Description	In this outcome measure, number of participants who survived at completion of InO treatment were reported.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	8
Count of Participants [Participants]	8 28.6%

30. Secondary Outcome

Title	Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment
Description	VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Participants With VOD/SOS	2 7.1%
Participants Not With VOD/SOS	26 92.9%

31. Secondary Outcome

Title	Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)
Description	VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	2
Spironolactone	1 3.6%
Ursodeoxycholic Acid	1 3.6%

32. Secondary Outcome

Title	Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)
Description	VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	2
Count of Participants [Participants]	1 3.6%

33. Secondary Outcome

Title	Number of Participants With Interrupted InO Treatment Due to VOD/SOS
Description	VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	2
Count of Participants [Participants]	2 7.1%

34. Secondary Outcome

Title	Number of Participants With Moderate Severity VOD/SOS
Description	VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	2
Count of Participants [Participants]	2 7.1%

35. Secondary Outcome

Title	Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Grade 3	1 3.6%
Grade 4	1 3.6%

36. Secondary Outcome

Title	Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	2
Antibiotics/ Intensive Therapy Unit	1 3.6%
High dose septrin + Caspofungi	1 3.6%

37. Secondary Outcome

Title	Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	28
Count of Participants [Participants]	1 3.6%

38. Secondary Outcome

Title	Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	5
Count of Participants [Participants]	0 0%

39. Secondary Outcome

Title	Number of Participants With Significant Risk Factors for VOD/SOS
Description	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
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
Measure Participants	9
Experienced VOD/SOS: Yes	1 3.6%
Experienced VOD/SOS: No	7 25%
Experienced VOD/SOS: Yes	0 0%
Experienced VOD/SOS: No	1 3.6%
Experienced VOD/SOS: Yes	1 3.6%
Experienced VOD/SOS: No	8 28.6%
Experienced VOD/SOS: Yes	0 0%
Experienced VOD/SOS: No	1 3.6%
Experienced VOD/SOS: Yes	1 3.6%
Experienced VOD/SOS: No	6 21.4%
Experienced VOD/SOS: Yes	0 0%
Experienced VOD/SOS: No	1 3.6%
Experienced VOD/SOS: Yes	1 3.6%
Experienced VOD/SOS: No	7 25%
Experienced VOD/SOS: Yes	0 0%
Experienced VOD/SOS: No	1 3.6%
Experienced VOD/SOS: Yes	1 3.6%
Experienced VOD/SOS: No	7 25%
Experienced VOD/SOS: Yes	0 0%
Experienced VOD/SOS: No	1 3.6%
Experienced VOD/SOS: Yes	0 0%
Experienced VOD/SOS: No	1 3.6%
Experienced VOD/SOS: Yes	1 3.6%
Experienced VOD/SOS: No	7 25%

Adverse Events

Time Frame	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
Adverse Event Reporting Description	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.
Arm/Group Title	Inotuzumab Ozogamicin (InO)
Arm/Group Description	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.
All Cause Mortality
	Inotuzumab Ozogamicin (InO)
	Affected / at Risk (%)	# Events
Total	19/28 (67.9%)
Serious Adverse Events
	Inotuzumab Ozogamicin (InO)
	Affected / at Risk (%)	# Events
Total	2/28 (7.1%)
General disorders
Lung	2/28 (7.1%)
Other (Not Including Serious) Adverse Events
	Inotuzumab Ozogamicin (InO)
	Affected / at Risk (%)	# Events
Total	2/28 (7.1%)
General disorders
Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)	2/28 (7.1%)
Liver	1/28 (3.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.