Trial Outcomes & Findings for A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (NCT NCT05687032)

Last Updated: 2025-12-03

Results Overview

CR: disappearance of leukemia as indicated by \<5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) \>=1000 per microliter (/mcL) and platelets \>=100,000/mcL. C1 extramedullary disease (EMD) status was required (disappearance of all measurable and non-measurable EMD with the exception of lesions for which following must be true: participants with at least 1 measurable lesion, all nodal masses \>1.5 centimeter (cm) in greatest transverse diameter (GTD) at baseline regressed to \<=1.5 cm in GTD and nodal masses \>=1 cm and \<=1.5 cm in GTD at baseline must have regressed to \<1 cm GTD or reduced by 75% in sum of products of greatest diameters (SPD). No new lesions. Spleen and other previously enlarged organs must have regressed in size and must not be palpable. All diseases were assessed using the same technique as at baseline. CRi: CR except with ANC \<1000/mcL and/or platelets \<100,000/mcL.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

44 participants

Primary outcome timeframe

From InO treatment initiation on Day 1 to CR or CRi (maximum up to 30.1 weeks of treatment exposure)

Results posted on

2025-12-03

Participant Flow

A total of 44 participants were assigned to and received study treatment.

Results are reported at Primary Completion Date, and data is disclosed for only those outcome measures whose analysis were final. Remaining outcome measures' data would be reported upon their complete analyses at study completion.

Participant milestones

Participant milestones
Measure	Inotuzumab Ozogamicin (InO) Participants received intravenous (IV) infusion of InO as 0.8 milligram per square meter (mg/m\^2) on Week 1, 0.5 mg/m\^2 on Week2 and 3 every 21-28 days cycle. After Cycle 1: a) participants who achieved desired response, received IV infusion of InO as 0.5 mg/m\^2 on Week 1, Week2 and 3 of subsequent cycles (1 cycle = 28 days); b) participants who did not achieve desired response, received IV infusion of InO as 0.8 mg/m\^2 on Week 1 and 0.5 mg/m\^2 on Week2 and 3 of subsequent cycles (1 cycle = 28 days). Participants who did not achieve desired response within 3 cycles discontinued treatment. Desired response was complete remission or complete remission with incomplete hematologic recovery.
Treatment Phase STARTED	44
Treatment Phase COMPLETED	13
Treatment Phase NOT COMPLETED	31
Follow-Up Phase STARTED	42
Follow-Up Phase COMPLETED	0
Follow-Up Phase NOT COMPLETED	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Inotuzumab Ozogamicin (InO) Participants received intravenous (IV) infusion of InO as 0.8 milligram per square meter (mg/m\^2) on Week 1, 0.5 mg/m\^2 on Week2 and 3 every 21-28 days cycle. After Cycle 1: a) participants who achieved desired response, received IV infusion of InO as 0.5 mg/m\^2 on Week 1, Week2 and 3 of subsequent cycles (1 cycle = 28 days); b) participants who did not achieve desired response, received IV infusion of InO as 0.8 mg/m\^2 on Week 1 and 0.5 mg/m\^2 on Week2 and 3 of subsequent cycles (1 cycle = 28 days). Participants who did not achieve desired response within 3 cycles discontinued treatment. Desired response was complete remission or complete remission with incomplete hematologic recovery.
Treatment Phase Adverse Event	13
Treatment Phase Death	1
Treatment Phase Physician Decision	3
Treatment Phase Progressive disease	9
Treatment Phase Withdrawal by Subject	5
Follow-Up Phase Death	16
Follow-Up Phase Ongoing	26

Baseline Characteristics

A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inotuzumab Ozogamicin (InO) n=44 Participants Participants received IV infusion of InO as 0.8 mg/m\^2 on Week 1, 0.5 mg/m\^2 on Week2 and 3 every 21-28 days cycle. After Cycle 1: a) participants who achieved desired response, received IV infusion of InO as 0.5 mg/m\^2 on Week 1, Week2 and 3 of subsequent cycles (1 cycle = 28 days); b) participants who did not achieve desired response, received IV infusion of InO as 0.8 mg/m\^2 on Week 1 and 0.5 mg/m\^2 on Week2 and 3 of subsequent cycles (1 cycle = 28 days). Participants who did not achieve desired response within 3 cycles discontinued treatment. Desired response was complete remission or complete remission with incomplete hematologic recovery.
Age, Customized Age · 18 to less than 45 years	22 Participants n=3 Participants
Age, Customized Age · 45 to less than 65 years	14 Participants n=3 Participants
Age, Customized Age · Greater than or equal to 65 years	8 Participants n=3 Participants
Sex: Female, Male Female	22 Participants n=3 Participants
Sex: Female, Male Male	22 Participants n=3 Participants
Race/Ethnicity, Customized Race - Asian	44 Participants n=3 Participants
Racial Designation Han Chinese	43 Participants n=3 Participants
Racial Designation Not disclosed	1 Participants n=3 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade 0	10 Participants n=3 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade 1	29 Participants n=3 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade 2	5 Participants n=3 Participants
Cytogenetics Characteristics Abnormal: Ph-positive	11 Participants n=3 Participants
Cytogenetics Characteristics Abnormal: T(4;11)-positive	2 Participants n=3 Participants
Cytogenetics Characteristics Abnormal: DEL(9P)	2 Participants n=3 Participants
Cytogenetics Characteristics Abnormal: Other	16 Participants n=3 Participants
Cytogenetics Characteristics Normal	20 Participants n=3 Participants
Cytogenetics Characteristics Unknown	1 Participants n=3 Participants
Number of Participants According to Salvage Therapy Salvage Therapy 1	23 Participants n=3 Participants
Number of Participants According to Salvage Therapy Salvage Therapy 2	21 Participants n=3 Participants
Number of Participants With Prior Transplant	5 Participants n=3 Participants

PRIMARY outcome

Timeframe: From InO treatment initiation on Day 1 to CR or CRi (maximum up to 30.1 weeks of treatment exposure)

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention. Data collected after the end of treatment or after new anti-cancer therapy was excluded.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin (InO) n=44 Participants Participants received IV infusion of InO as 0.8 mg/m\^2 on Week 1, 0.5 mg/m\^2 on Week2 and 3 every 21-28 days cycle. After Cycle 1: a) participants who achieved desired response, received IV infusion of InO as 0.5 mg/m\^2 on Week 1, Week2 and 3 of subsequent cycles (1 cycle = 28 days); b) participants who did not achieve desired response, received IV infusion of InO as 0.8 mg/m\^2 on Week 1 and 0.5 mg/m\^2 on Week2 and 3 of subsequent cycles (1 cycle = 28 days). Participants who did not achieve desired response within 3 cycles discontinued treatment. Desired response was complete remission or complete remission with incomplete hematologic recovery.
Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) as Per Investigator's Assessment According to a Modified Cheson Criteria CR/CRi	81.8 Percentage of participants Interval 70.4 to 93.2
Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) as Per Investigator's Assessment According to a Modified Cheson Criteria CR	47.7 Percentage of participants Interval 33.0 to 62.5
Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) as Per Investigator's Assessment According to a Modified Cheson Criteria CRi	34.1 Percentage of participants Interval 20.1 to 48.1

SECONDARY outcome

Timeframe: From date of first response in responders (CR/CRi) to the date of disease progression (objective progression, relapse from CR/CRi), death due to any cause, whichever occurred first (including post-study treatment follow-up disease assessment)

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention.

DoR: from date of first CR/CRi to date of disease progression (objective progression, relapse from CR/CRi), death due to any cause, whichever occurred first. CR: disappearance of leukemia as indicated by \<5% marrow blasts and absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC \>=1000 per microliter (/mcL) and platelets \>=10\^5/mcL. C1 EMD status was required (disappearance of all measurable and non-measurable EMD with the exception of lesions for which following must be true: participants with at least 1 measurable lesion, all nodal masses \>1.5 cm in GTD at baseline regressed to \<=1.5 cm in GTD and nodal masses \>=1 cm and \<=1.5 cm in GTD at baseline must have regressed to \<1 cm GTD or reduced by 75% in SPD. No new lesions. Spleen and other previously enlarged organs must have regressed in size and must not be palpable. All diseases must be assessed using same technique as at baseline. CRi: CR except with ANC \<1000/mcL and/or platelets \<10\^5/mcL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From CR/CRi till MRD negativity achieved (maximum up to 30.1 weeks of treatment exposure)

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies participants who achieved CR/CRi and were evaluated for this outcome measure.

MRD negativity was defined as malignant B lymphocytes occurring at frequency \<10\^4. CR: disappearance of leukemia as indicated by \<5% marrow blasts and absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC \>=1000 per microliter (/mcL) and platelets \>=10\^5/mcL. C1 EMD status was required (disappearance of all measurable and non-measurable EMD with the exception of lesions for which following must be true: participants with at least 1 measurable lesion, all nodal masses \>1.5 cm in GTD at baseline regressed to \<=1.5 cm in GTD and nodal masses \>=1 cm and \<=1.5 cm in GTD at baseline must have regressed to \<1 cm GTD or reduced by 75% in SPD. No new lesions. Spleen and other previously enlarged organs must have regressed in size and must not be palpable. All diseases must be assessed using same technique as at baseline. CRi: CR except with ANC \<1000/mcL and/or platelets \<10\^5/mcL.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin (InO) n=36 Participants Participants received IV infusion of InO as 0.8 mg/m\^2 on Week 1, 0.5 mg/m\^2 on Week2 and 3 every 21-28 days cycle. After Cycle 1: a) participants who achieved desired response, received IV infusion of InO as 0.5 mg/m\^2 on Week 1, Week2 and 3 of subsequent cycles (1 cycle = 28 days); b) participants who did not achieve desired response, received IV infusion of InO as 0.8 mg/m\^2 on Week 1 and 0.5 mg/m\^2 on Week2 and 3 of subsequent cycles (1 cycle = 28 days). Participants who did not achieve desired response within 3 cycles discontinued treatment. Desired response was complete remission or complete remission with incomplete hematologic recovery.
Percentage of Participants With Minimal Residual Disease (MRD) Negativity Among Who Achieved CR/CRi	69.4 Percentage of participants Interval 51.9 to 83.7

SECONDARY outcome

Timeframe: From date of first dose to the date of disease progression (objective progression, relapse from CR/CRi), or death due to any cause, whichever occurred first

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention.

PFS: from date of first dose to date of disease progression (objective progression, relapse from CR/CRi), or death due to any cause, whichever occurred first. CR: disappearance of leukemia as indicated by \<5% marrow blasts and absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC \>=1000 per microliter (/mcL) and platelets \>=10\^5/mcL. C1 EMD status was required (disappearance of all measurable and non-measurable EMD with the exception of lesions for which following must be true: participants with at least 1 measurable lesion, all nodal masses \>1.5 cm in GTD at baseline regressed to \<=1.5 cm in GTD and nodal masses \>=1 cm and \<=1.5 cm in GTD at baseline must have regressed to \<1 cm GTD or reduced by 75% in SPD. No new lesions. Spleen and other previously enlarged organs must have regressed in size and must not be palpable. All diseases must be assessed using same technique as at baseline. CRi: CR except with ANC \<1000/mcL and/or platelets \<10\^5/mcL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose to the date of death due to any cause or censoring, whichever occurred first

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention.

OS was defined as the time from date of first dose to the date of death due to any cause. Participants without confirmation of death were to be censored on date of last contact.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From InO treatment initiation till study completion

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention.

Participants who proceeded to HSCT was reported. HSCT is a procedure where multipotent hematopoietic stem cells are transplanted from sources such as bone marrow, peripheral blood, or umbilical cord blood. These stem cells can replicate inside a participant and produce additional normal blood cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From InO treatment initiation till study completion

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention.

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated; Grade 5= death related to AE. An AE was considered treatment-emergent relative to a given treatment if the event start date is during the on-treatment period (including on the date of first dose).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From InO treatment initiation till study completion

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention.

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated, Grade 5= death related to AE. An AE was considered treatment-emergent relative to a given treatment if the event start date is during the on-treatment period (including on the date of first dose).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From InO treatment initiation till study completion

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention.

An AE was defined as any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated, Grade 5= death related to AE. An AE was considered treatment-emergent relative to a given treatment if event start date is during on-treatment period (including on date of first dose). Relatedness to study drug was assessed by investigator.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From InO treatment initiation till study completion

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention.

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated, Grade 5= death related to AE.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From InO treatment initiation till study completion

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention.

Hematology parameters included white blood cell count (with differential including blast count1), hemoglobin and platelet count. Grade 2: moderate; minimal, local or noninvasive intervention indicated; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care; Grade 4: life-threatening consequences.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From InO treatment initiation till study completion

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention.

Chemistry parameters included sodium, potassium, magnesium, calcium, creatinine, albumin, alanine aminotransferase, aspartate aminotransferase, glucose, phosphorus, total bilirubin, direct bilirubin only if total is elevated, blood urea nitrogen or urea, uric acid or urate, alkaline phosphatase, lactate dehydrogenase, gamma glutamyl transpeptidase, total protein, amylase and/or lipase. Grade 2: moderate; minimal, local or noninvasive intervention indicated; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care; Grade 4: life-threatening consequences.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From InO treatment initiation till study completion

Population: Safety population included all enrolled participants who received at least 1 dose of study intervention.

Criteria for VOD were defined as (i) classical VOD (first 21 days after HSCT): bilirubin greater than or equal to 2 mg/dL and two (or more) of the following criteria must also be present; painful hepatomegaly, weight gain \>5%, ascites. (ii) late onset VOD (\>21 days after HSCT): classical VOD beyond day 21 or histologically proven VOD; or two or more of the following criteria must be present: bilirubin \>2 mg/dL; painful hepatomegaly; weight gain \>5%; ascites.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: Pre-dose (0 hour), 1, 2 and 4 hours post-dose on Day 1; Cycle 4: Pre-dose (0 hour), and 1 hour post-dose on Day 1

Population: Pharmacokinetic (PK) concentration population included subset of the safety analysis set and included participants who had at least one post-dose concentration measurement above the lower limit of quantitation (LLQ) for inotuzumab ozogamicin. Here, 'Number Analyzed' signifies participants evaluable at specific timepoints.

Cmax was defined as maximum observed plasma concentration. Cmax was observed directly from data.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin (InO) n=44 Participants Participants received IV infusion of InO as 0.8 mg/m\^2 on Week 1, 0.5 mg/m\^2 on Week2 and 3 every 21-28 days cycle. After Cycle 1: a) participants who achieved desired response, received IV infusion of InO as 0.5 mg/m\^2 on Week 1, Week2 and 3 of subsequent cycles (1 cycle = 28 days); b) participants who did not achieve desired response, received IV infusion of InO as 0.8 mg/m\^2 on Week 1 and 0.5 mg/m\^2 on Week2 and 3 of subsequent cycles (1 cycle = 28 days). Participants who did not achieve desired response within 3 cycles discontinued treatment. Desired response was complete remission or complete remission with incomplete hematologic recovery.
Maximum Plasma Concentration (Cmax) of InO on Day 1 of Cycle 1 and Cycle 4 Day 1_Cycle 1	273.3 Nanogram per milliliter Standard Deviation 105.53
Maximum Plasma Concentration (Cmax) of InO on Day 1 of Cycle 1 and Cycle 4 Day 1_Cycle 4	342.6 Nanogram per milliliter Standard Deviation 409.97

SECONDARY outcome

Timeframe: Pre-dose (0 hour) on Day 1 of Cycle 4

Population: PK concentration population included subset of the safety analysis set and included participants who had at least one post-dose concentration measurement above the LLQ for inotuzumab ozogamicin. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Ctrough was observed directly from data.

Outcome measures

Outcome measures
Measure	Inotuzumab Ozogamicin (InO) n=22 Participants Participants received IV infusion of InO as 0.8 mg/m\^2 on Week 1, 0.5 mg/m\^2 on Week2 and 3 every 21-28 days cycle. After Cycle 1: a) participants who achieved desired response, received IV infusion of InO as 0.5 mg/m\^2 on Week 1, Week2 and 3 of subsequent cycles (1 cycle = 28 days); b) participants who did not achieve desired response, received IV infusion of InO as 0.8 mg/m\^2 on Week 1 and 0.5 mg/m\^2 on Week2 and 3 of subsequent cycles (1 cycle = 28 days). Participants who did not achieve desired response within 3 cycles discontinued treatment. Desired response was complete remission or complete remission with incomplete hematologic recovery.
Pre-dose Concentration (Ctrough) of InO on Day 1 of Cycle 4	85.33 Nanogram per milliliter Standard Deviation 30.493

SECONDARY outcome

Timeframe: From InO treatment initiation till study completion

Population: Immunogenicity population included subset of the safety analysis set and included participants who received at least 1 dose of investigational product (inotuzumab ozogamicin) and had at least one ADA or NAb sample collected for immunogenicity.

A participant was ADA or NAb positive if (i) baseline titer was missing or negative and participant had \>=1 post treatment positive titer (treatment-induced), or (ii) positive titer at baseline and had a \>=0.602 unit increase in titer (log10) from baseline in \>=1 post-treatment sample (treatment-boosted).

Outcome measures

Outcome data not reported

Adverse Events

Inotuzumab Ozogamicin (InO)

Serious events: 20 serious events

Other events: 44 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Inotuzumab Ozogamicin (InO) n=44 participants at risk Participants received IV infusion of InO as 0.8 mg/m\^2 on Week 1, 0.5 mg/m\^2 on Week2 and 3 every 21-28 days cycle. After Cycle 1: a) participants who achieved desired response, received IV infusion of InO as 0.5 mg/m\^2 on Week 1, Week2 and 3 of subsequent cycles (1 cycle = 28 days); b) participants who did not achieve desired response, received IV infusion of InO as 0.8 mg/m\^2 on Week 1 and 0.5 mg/m\^2 on Week2 and 3 of subsequent cycles (1 cycle = 28 days). Participants who did not achieve desired response within 3 cycles discontinued treatment. Desired response was complete remission or complete remission with incomplete hematologic recovery.
Blood and lymphatic system disorders Anaemia	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Febrile neutropenia	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Leukostasis syndrome	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Myelosuppression	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Cardiac disorders Cardiac failure acute	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Cardiac disorders Cardiopulmonary failure	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
General disorders Disease progression	4.5% 2/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
General disorders Pyrexia	4.5% 2/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Hepatobiliary disorders Drug-induced liver injury	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Hepatobiliary disorders Liver injury	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Hepatobiliary disorders Venoocclusive liver disease	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Bronchopulmonary aspergillosis	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations COVID-19	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Gastroenteritis	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Infection	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Pneumocystis jirovecii pneumonia	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Pneumonia	9.1% 4/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Soft tissue infection	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Blood bilirubin increased	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Neutrophil count decreased	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Platelet count decreased	13.6% 6/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations White blood cell count decreased	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Tumour lysis syndrome	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Asthma	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Emphysema	2.3% 1/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.

Other adverse events

Other adverse events
Measure	Inotuzumab Ozogamicin (InO) n=44 participants at risk Participants received IV infusion of InO as 0.8 mg/m\^2 on Week 1, 0.5 mg/m\^2 on Week2 and 3 every 21-28 days cycle. After Cycle 1: a) participants who achieved desired response, received IV infusion of InO as 0.5 mg/m\^2 on Week 1, Week2 and 3 of subsequent cycles (1 cycle = 28 days); b) participants who did not achieve desired response, received IV infusion of InO as 0.8 mg/m\^2 on Week 1 and 0.5 mg/m\^2 on Week2 and 3 of subsequent cycles (1 cycle = 28 days). Participants who did not achieve desired response within 3 cycles discontinued treatment. Desired response was complete remission or complete remission with incomplete hematologic recovery.
Blood and lymphatic system disorders Anaemia	70.5% 31/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Coagulopathy	9.1% 4/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Leukocytosis	11.4% 5/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Leukopenia	15.9% 7/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal distension	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Constipation	20.5% 9/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	13.6% 6/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	38.6% 17/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	25.0% 11/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
General disorders Chest discomfort	11.4% 5/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
General disorders Fatigue	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
General disorders Oedema peripheral	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
General disorders Pyrexia	36.4% 16/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Hepatobiliary disorders Hepatic function abnormal	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Hepatobiliary disorders Hyperbilirubinaemia	13.6% 6/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations COVID-19	18.2% 8/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Febrile infection	13.6% 6/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Influenza	11.4% 5/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Pneumonia	22.7% 10/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Respiratory tract infection	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Upper respiratory tract infection	11.4% 5/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Infections and infestations Urinary tract infection	11.4% 5/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Activated partial thromboplastin time prolonged	18.2% 8/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Alanine aminotransferase increased	29.5% 13/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Alpha hydroxybutyrate dehydrogenase increased	18.2% 8/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Aspartate aminotransferase increased	54.5% 24/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Blood alkaline phosphatase increased	18.2% 8/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Blood bilirubin increased	50.0% 22/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Blood lactate dehydrogenase increased	52.3% 23/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Electrocardiogram QT prolonged	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Electrocardiogram T wave abnormal	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Eosinophil count decreased	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Fibrin D dimer increased	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Gamma-glutamyltransferase increased	25.0% 11/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Lipase increased	18.2% 8/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Lymphocyte count decreased	79.5% 35/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Lymphocyte count increased	11.4% 5/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Monocyte count decreased	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Monocyte count increased	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Neutrophil count decreased	95.5% 42/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Platelet count decreased	93.2% 41/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Weight decreased	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations Weight increased	11.4% 5/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Investigations White blood cell count decreased	88.6% 39/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Decreased appetite	18.2% 8/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Fluid retention	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypercholesterolaemia	15.9% 7/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperglycaemia	22.7% 10/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperphosphataemia	11.4% 5/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypertriglyceridaemia	25.0% 11/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperuricaemia	36.4% 16/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypoalbuminaemia	40.9% 18/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypocalcaemia	38.6% 17/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypochloraemia	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypokalaemia	61.4% 27/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypomagnesaemia	29.5% 13/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyponatraemia	18.2% 8/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypoproteinaemia	9.1% 4/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Sodium retention	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Nervous system disorders Dizziness	9.1% 4/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Nervous system disorders Headache	9.1% 4/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Psychiatric disorders Insomnia	6.8% 3/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash	13.6% 6/44 • From first dose of study drug up to 9 weeks after the last dose of the study drug (maximum up to 39.1 weeks) Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all enrolled participants who received at least 1 dose of study intervention.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER