Trial Outcomes & Findings for Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma (NCT NCT00867087)

Last Updated: 2017-12-05

Results Overview

Response criteria based on National Cancer Institute (NCI) International Response Criteria for non-Hodgkin's lymphoma. CR: no detectable clinical \& radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (less than or equal to \[≤\] 1.5 cm in greatest transverse diameter for nodes greater than \[\>\] 1.5 cm pre-therapy); spleen \& other organs (if enlarged pre-therapy) regressed in size \& spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: \> or equal to (≥) 50% decrease in sum of product diameters (SPD) of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic \& hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable \& no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment after treatment were partial responders.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

Up to 2 years (9 weeks of 3 21-day cycles and every 3 to 6 months during the long-term follow-up period)

Results posted on

2017-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 Intravenous (IV) inotuzumab ozogamicin 1.8 milligrams per square meter (mg/m\^2) given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Overall Study STARTED	63
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 Intravenous (IV) inotuzumab ozogamicin 1.8 milligrams per square meter (mg/m\^2) given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Overall Study Other	1
Overall Study Withdrawal by Subject	4
Overall Study Death	37

Baseline Characteristics

Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Age, Continuous	57.7 Years STANDARD_DEVIATION 12.92 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years (9 weeks of 3 21-day cycles and every 3 to 6 months during the long-term follow-up period)

Population: Intention-to-treat (ITT) population - included all participants enrolled into the study. Response includes confirmed CR/PR and unconfirmed CR/PR.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy	28.6 Percentage of Participants Interval 17.89 to 41.35

SECONDARY outcome

Timeframe: 6 months after the first dose of inotuzumab ozogamicin

Population: ITT population

PFS; time from date of randomization to earliest date of progression, relapse after CR, death from any cause without progression, start of new treatment for the lymphoma excluding treatments/procedures for consolidation therapy in this protocol, or censored at date of last tumor assessment. Progression: abnormal lymph nodes (long axis \> 1.5 cm or long axis 1.1 to 1.5 cm and short axis \> 1.0 cm); appearance of any new lesion \> 1.5 cm in any axis during or at end of treatment; ≥ 50% increase from nadir in SPD of any previously involved nodes, in a single involved node, or in the size of other lesions; ≥ 50% increase in longest diameter of any single previously identified node \> 1.0 cm in short axis.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Kaplan-Meier Estimate of Progression Free Survival (PFS) 6 Months After Inotuzumab Ozogamicin Plus Rituximab Therapy	39.1 Percentage of Participants Interval 26.9 to 51.1

SECONDARY outcome

Timeframe: 2 years after the first dose of inotuzumab ozogamicin

Population: ITT population

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Kaplan-Meier Estimate of PFS 2 Years After Inotuzumab Ozogamicin Plus Rituximab Therapy	25.3 Percentage of Participants Interval 15.1 to 36.8

SECONDARY outcome

Timeframe: From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks) and up to approximately 2 to 3 weeks after 6 cycles (up to 21 weeks).

Population: ITT population

Successful mobilization of PBSC: ≥ 2 x 10\^6 cluster of differentiation (CD) 34+ cells per kilogram (cells/kg) after 3 cycles. CR: no detectable clinical \& radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (≤ 1.5 cm in greatest transverse diameter for nodes \> 1.5 cm pre-therapy); spleen \& other organs (if enlarged pre-therapy) regressed in size \& spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: ≥ 50% decrease in SPD of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic \& hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable \& no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment post treatment were partial responders. Response includes confirmed CR/PR and unconfirmed CR/PR.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Percentage of Participants With a Response of CR or PR and Who Had Successful Granulocyte Colony Stimulating Factor (G-CSF) Mobilization of Peripheral Blood Stem Cells (PBSCs) Overall and After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy Overall	17.5 Percentage of Participants Interval 9.05 to 29.1
Percentage of Participants With a Response of CR or PR and Who Had Successful Granulocyte Colony Stimulating Factor (G-CSF) Mobilization of Peripheral Blood Stem Cells (PBSCs) Overall and After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy After 3 cycles	15.9 Percentage of Participants Interval 7.88 to 27.26

SECONDARY outcome

Timeframe: From the first dose to approximately 2 to 3 weeks after up to 6 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 21 weeks).

Population: ITT population

Successful mobilization of PBSC was defined as ≥ 2 x 10\^6 CD34+ cells/kg collected after 3 cycles of inotuzumab ozogamicin plus rituximab therapy.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Percentage of Participants With Successful G-CSF Mobilization of PBSC	28.6 Percentage of Participants Interval 17.89 to 41.35

SECONDARY outcome

Timeframe: A minimum of 4 weeks and a maximum of 8 weeks after the last cycle of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 26 weeks).

Population: ITT population

Participants underwent high dose chemotherapy and aSCT. In order to proceed to aSCT, participants were required to achieve CR or PR and successful collection of PSBC (≥ 2.0 x 10\^6 CD34+ cells/kg collected after 3 cycles).

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Percentage of Participants Who Underwent Autologous Stem Cell Transplant (aSCT)	28.6 Percentage of Participants Interval 17.89 to 41.35

SECONDARY outcome

Timeframe: From the completion of aSCT through 2 year long-term follow-up period, including but not limited to planned assessments scheduled every 3 to 6 months.

Population: ITT population. Only participants who underwent aSCT were included in the analysis.

EFS was the time (in months) from the date of aSCT to the earliest date of progression, relapse after CR, death from any cause without progression, initiation of a new treatment for the lymphoma or was censored at the date of the last tumor assessment.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=18 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Event-Free Survival (EFS) After aSCT	NA Months Interval 4.1 to There were insufficient events to estimate the median and the upper bound of the 95% CI at the time of data analysis.

SECONDARY outcome

Timeframe: From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks).

Population: ITT population

CR: complete disappearance of all detectable clinical \& radiographic evidence of disease \& disease-related symptoms; lymph nodes \& nodal masses regressed to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy); spleen and other organs (if enlarged prior to therapy) regressed in size \& spleen not palpable on physical examination; repeat bone marrow infiltrate clear. Response includes confirmed CR and unconfirmed CR.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Percentage of Participants With a CR After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy	12.7 Percentage of Participants Interval 5.65 to 23.5

SECONDARY outcome

Timeframe: From randomization until the date of death, or the date of last contact if no death occurred (up to 2 years).

Population: ITT population

OS was the time (in months) from the date of randomization to the date of death, and censored at the date of last contact if no death occurred.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Overall Survival (OS)	12.5 Months Interval 9.6 to Upper 95% CI could not be determined due to the pattern of censorship with respect to events.

SECONDARY outcome

Timeframe: Within 3 days prior each dose of test article, on Day -2, 1, 8, and 15 of Cycles 1 to 3, 2 to 3 weeks after Cycle 3, at the end-of-treatment visit, and every 3 to 6 months during long-term follow-up (up to 2 years).

Population: Safety population

The following parameters were analyzed for serum chemistry; blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. The following parameters were analyzed for hematology; lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE v3.0).

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Percentage of Participants With Any Grade 3/4 Laboratory Abnormality During Therapy	92.1 Percentage of Participants

SECONDARY outcome

Timeframe: Treatment emergent AEs were collected from time of first dose to end of trial visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs were collected from informed consent until end of trial visit (up to 6 months).

Population: Safety population Summary excludes events occurring after start of consolidation treatment.

An AE was any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory/physiologic observations occurring in a participant given a test article or in a clinical study; the event may not necessarily have had a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; cancer. Treatment-emergent AEs were AEs that emerged after the first dose of the study treatment during the treatment period that were absent pre-treatment, or worsened during the treatment period relative to the pre-treatment state. The severity of all AEs was graded by the investigator using the NCI Common Terminology Criteria for AE Version 3.0 (CTCAE v3.0).

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 Participants IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment Participants with AEs	100.0 Percentage of Participants
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment Participants with SAEs	34.9 Percentage of Participants
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment Participants with AEs Grade ≥ 3	90.5 Percentage of Participants
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment Participants with dose delayed due to AEs	27.0 Percentage of Participants
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment Participants with dose reduced due to AEs	11.1 Percentage of Participants
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment Participants permanently discontinued due to AEs	9.5 Percentage of Participants

Adverse Events

Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2

Serious events: 29 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 participants at risk IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Blood and lymphatic system disorders Anaemia	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Blood and lymphatic system disorders Febrile bone marrow aplasia	3.2% 2/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Blood and lymphatic system disorders Febrile neutropenia	3.2% 2/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Blood and lymphatic system disorders Neutropenia	3.2% 2/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Blood and lymphatic system disorders Thrombocytopenia	12.7% 8/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Congenital, familial and genetic disorders Aplasia	3.2% 2/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Gastrointestinal disorders Abdominal pain	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Gastrointestinal disorders Ascites	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Gastrointestinal disorders Melaena	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Gastrointestinal disorders Nausea	3.2% 2/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
General disorders General physical health deterioration	3.2% 2/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
General disorders Multi-organ disorder	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
General disorders Multi-organ failure	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
General disorders Oedema	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
General disorders Pyrexia	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Hepatobiliary disorders Hepatitis	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Hepatobiliary disorders Hyperbilirubinaemia	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Hepatobiliary disorders Venoocclusive liver disease	3.2% 2/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Bronchopneumonia	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Candidiasis	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Cellulitis	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Device related infection	3.2% 2/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Enterobacter infection	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Enterobacter pneumonia	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Klebsiella bacteraemia	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Lower respiratory tract infection	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Neutropenic sepsis	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Pneumonia	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Sepsis	3.2% 2/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Staphylococcal infection	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Streptococcal sepsis	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Urinary tract infection enterococcal	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Investigations Blood creatinine increased	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Investigations Platelet count decreased	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Metabolism and nutrition disorders Decreased appetite	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Metabolism and nutrition disorders Hypercalcaemia	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Nervous system disorders Encephalopathy	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Psychiatric disorders Delirium	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Renal and urinary disorders Renal failure	3.2% 2/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Renal and urinary disorders Renal failure acute	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Vascular disorders Hypotension	1.6% 1/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.

Other adverse events

Other adverse events
Measure	Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2 n=63 participants at risk IV inotuzumab ozogamicin 1.8 mg/m\^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m\^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
Blood and lymphatic system disorders Anaemia	14.3% 9/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Blood and lymphatic system disorders Febrile neutropenia	6.3% 4/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Blood and lymphatic system disorders Leukopenia	23.8% 15/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Blood and lymphatic system disorders Lymphopenia	39.7% 25/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Blood and lymphatic system disorders Neutropenia	34.9% 22/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Blood and lymphatic system disorders Thrombocytopenia	68.3% 43/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Gastrointestinal disorders Abdominal pain	17.5% 11/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Gastrointestinal disorders Constipation	25.4% 16/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Gastrointestinal disorders Diarrhoea	28.6% 18/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Gastrointestinal disorders Dyspepsia	7.9% 5/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Gastrointestinal disorders Flatulence	6.3% 4/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Gastrointestinal disorders Nausea	50.8% 32/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Gastrointestinal disorders Vomiting	25.4% 16/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
General disorders Chills	11.1% 7/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
General disorders Fatigue	41.3% 26/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
General disorders Mucosal inflammation	11.1% 7/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
General disorders Oedema peripheral	12.7% 8/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
General disorders Pain	9.5% 6/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
General disorders Pyrexia	33.3% 21/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Hepatobiliary disorders Hyperbilirubinaemia	12.7% 8/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Infections and infestations Upper respiratory tract infection	6.3% 4/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Investigations Alanine aminotransferase increased	14.3% 9/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Investigations Aspartate aminotransferase increased	42.9% 27/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Investigations Blood alkaline phosphatase increased	23.8% 15/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Investigations Blood lactate dehydrogenase increased	11.1% 7/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Metabolism and nutrition disorders Decreased appetite	14.3% 9/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Metabolism and nutrition disorders Hyperglycaemia	7.9% 5/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	7.9% 5/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Metabolism and nutrition disorders Hypocalcaemia	7.9% 5/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Metabolism and nutrition disorders Hypokalaemia	20.6% 13/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Metabolism and nutrition disorders Hypophosphataemia	15.9% 10/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Musculoskeletal and connective tissue disorders Arthralgia	7.9% 5/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Musculoskeletal and connective tissue disorders Back pain	9.5% 6/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Musculoskeletal and connective tissue disorders Myalgia	6.3% 4/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Nervous system disorders Dizziness	11.1% 7/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Nervous system disorders Headache	22.2% 14/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Nervous system disorders Lethargy	9.5% 6/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Psychiatric disorders Insomnia	12.7% 8/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.1% 7/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Skin and subcutaneous tissue disorders Rash	6.3% 4/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.
Vascular disorders Flushing	6.3% 4/63 • AEs collected from informed consent to end of treatment visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs collected from informed consent until end of treatment visit for all participants (up to 6 months). The same event may appear as both an AE \& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \& non-serious in another, or 1 participant may have experienced both a serious \& non-serious event during the study. Summaries inclusive of events occurring after start of consolidation treatment.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee
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Restriction type: LTE60