Trial Outcomes & Findings for Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma (NCT NCT03570892)

Last Updated: 2026-01-06

Results Overview

Event-free survival (EFS) is defined as the time from the date of randomization to the date of the first documented disease progression or stable disease at or after the week 12 (+/- 1 week) assessment, as assessed by Blinded Independent Review Committee (BIRC) per Lugano criteria, or death due to any cause, at any time.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

331 participants

Primary outcome timeframe

appro. 24 months

Results posted on

2026-01-06

Participant Flow

The study was conducted in 18 countries and 65 sites. Approximately 318 subjects were planned to be randomized; 322 subjects were analyzed.

During the screening period, no lymphoma-specific therapy was allowed prior to randomization. During randomization, subjects were stratified by: Remission duration, international prognostic index (IPI) score and region.

Participant milestones

Participant milestones
Measure	Tisagenlecleucel Treatment Strategy Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel	Standard of Care Treatment Strategy Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)
Overall Study STARTED	162	160
Overall Study COMPLETED	105	106
Overall Study NOT COMPLETED	57	54

Reasons for withdrawal

Reasons for withdrawal
Measure	Tisagenlecleucel Treatment Strategy Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel	Standard of Care Treatment Strategy Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)
Overall Study Death	51	45
Overall Study Subject decision	5	3
Overall Study Protocol Violation	1	4
Overall Study Physician Decision	0	2

Baseline Characteristics

Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tisagenlecleucel Treatment Strategy n=162 Participants Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel	Standard of Care Treatment Strategy n=160 Participants Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)	Total n=322 Participants Total of all reporting groups
Age, Continuous	56.7 years STANDARD_DEVIATION 13.74 • n=37 Participants	55.0 years STANDARD_DEVIATION 12.99 • n=56 Participants	55.8 years STANDARD_DEVIATION 13.38 • n=82 Participants
Sex: Female, Male Female	59 Participants n=37 Participants	62 Participants n=56 Participants	121 Participants n=82 Participants
Sex: Female, Male Male	103 Participants n=37 Participants	98 Participants n=56 Participants	201 Participants n=82 Participants
Race/Ethnicity, Customized White	128 Participants n=37 Participants	128 Participants n=56 Participants	256 Participants n=82 Participants
Race/Ethnicity, Customized Asian	20 Participants n=37 Participants	22 Participants n=56 Participants	42 Participants n=82 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=37 Participants	3 Participants n=56 Participants	11 Participants n=82 Participants
Race/Ethnicity, Customized Unknown	4 Participants n=37 Participants	5 Participants n=56 Participants	9 Participants n=82 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=37 Participants	1 Participants n=56 Participants	2 Participants n=82 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=37 Participants	1 Participants n=56 Participants	2 Participants n=82 Participants

PRIMARY outcome

Timeframe: appro. 24 months

Population: The full analysis set (FAS) comprised all subjects to whom study treatment was assigned by randomization.

Outcome measures

Outcome measures
Measure	Tisagenlecleucel Treatment Strategy n=162 Participants Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel	Standard of Care Treatment Strategy n=160 Participants Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)
Event-free Survival (EFS) Per Blinded Independent Review Committee (BIRC) Assessment	3.0 months Interval 2.9 to 4.2	3.0 months Interval 3.0 to 3.5

SECONDARY outcome

Timeframe: 5 years

Event-free survival (EFS) is defined as the time from the date of randomization to the date of the first documented disease progression or stable disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Overall Response Rate (ORR) as per the Lugano criteria as per BIRC review and local investigator assessment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Duration of response: time from the date of first documented response of CR or PR to the date of first documented progression (SD or PD at or after the week 12 assessment will be considered progression) or death due to aggressive B-cell NHL. DOR will be summarized by BIRC and local response

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Time from the date of randomization to the date of a patient's first achieved a response of CR or PR on or after the Week 12 assessment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 Months

Time to definitive deterioration in SF-36v2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 Months

Time to definitive deterioration in FACT-Lym

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 Months

Time to definitive deterioration in EQ-VAS

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

qPCR will be used to measure tisagenlecleucel transgene concentrations in peripheral blood and bone marrow

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Pre-existing and treatment related immunogenicity (humoral and cellular) of tisagenlecleucel will be characterized.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

The presence of RCL will be assessed by VSV-qPCR in patients receiving tisagenlecleucel

Outcome measures

Outcome data not reported

Adverse Events

Tisagenlecleucel Treatment Strategy

Serious events: 76 serious events

Other events: 159 other events

Deaths: 52 deaths

Standard of Care Treatment Strategy

Serious events: 82 serious events

Other events: 158 other events

Deaths: 45 deaths

All Participants

Serious events: 158 serious events

Other events: 317 other events

Deaths: 97 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Tisagenlecleucel Treatment Strategy n=162 participants at risk Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel	Standard of Care Treatment Strategy n=160 participants at risk Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)	All Participants n=322 participants at risk All participants who were enrolled in the study
Blood and lymphatic system disorders Anaemia	1.2% 2/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	4.4% 7/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	2.8% 9/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Bone marrow failure	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Febrile neutropenia	8.6% 14/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	14.4% 23/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	11.5% 37/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Neutropenia	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Pancytopenia	2.5% 4/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	1.2% 4/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Thrombocytopenia	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	1.2% 2/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.93% 3/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Cardiac disorders Acute coronary syndrome	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Cardiac disorders Atrial fibrillation	1.2% 2/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	1.2% 2/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	1.2% 4/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Cardiac disorders Atrial flutter	0.00% 0/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Cardiac disorders Cardiac arrest	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 2/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Cardiac disorders Mitral valve disease	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Cardiac disorders Myocardial ischaemia	0.00% 0/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Cardiac disorders Ventricular tachycardia	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Abdominal pain	1.9% 3/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	3.1% 5/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	2.5% 8/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Abdominal pain lower	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Constipation	0.00% 0/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Diarrhoea	0.00% 0/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Faecaloma	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.2% 2/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 2/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Intestinal fistula	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Intestinal obstruction	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Mesenteric cyst	0.00% 0/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Nausea	1.9% 3/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	2.5% 4/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	2.2% 7/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Subileus	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Vomiting	1.2% 2/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	1.9% 3/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	1.6% 5/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Asthenia	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 2/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Catheter site inflammation	0.00% 0/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Chest pain	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 2/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Disease progression	3.7% 6/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	1.2% 2/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	2.5% 8/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Face oedema	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Fatigue	1.2% 2/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 2/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Malaise	0.00% 0/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Multiple organ dysfunction syndrome	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Pain	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 2/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Pyrexia	5.6% 9/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.0% 8/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.3% 17/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 1/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.31% 1/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Hepatobiliary disorders Hepatic failure	1.2% 2/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.62% 2/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.

Other adverse events
Measure	Tisagenlecleucel Treatment Strategy n=162 participants at risk Patients received investigator's choice of optional platinum-based immunochemotherapy followed by lymphodepleting chemotherapy and a single dose of tisagenlecleucel	Standard of Care Treatment Strategy n=160 participants at risk Patients received investigator's choice of platinum-based immunochemotherapy followed in responding patients by high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT)	All Participants n=322 participants at risk All participants who were enrolled in the study
Blood and lymphatic system disorders Anaemia	49.4% 80/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	71.2% 114/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	60.2% 194/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Febrile neutropenia	5.6% 9/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	13.8% 22/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	9.6% 31/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Leukopenia	13.6% 22/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	18.8% 30/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	16.1% 52/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Lymphopenia	7.4% 12/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	7.5% 12/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	7.5% 24/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Neutropenia	41.4% 67/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	40.6% 65/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	41.0% 132/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Blood and lymphatic system disorders Thrombocytopenia	36.4% 59/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	48.8% 78/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	42.5% 137/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Cardiac disorders Tachycardia	6.8% 11/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	1.9% 3/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	4.3% 14/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Ear and labyrinth disorders Tinnitus	1.2% 2/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.6% 9/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	3.4% 11/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Abdominal pain	9.3% 15/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	15.6% 25/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	12.4% 40/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Constipation	29.6% 48/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	25.6% 41/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	27.6% 89/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Diarrhoea	21.6% 35/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	35.6% 57/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	28.6% 92/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Nausea	41.4% 67/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	48.8% 78/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	45.0% 145/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Stomatitis	3.1% 5/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	10.0% 16/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	6.5% 21/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Gastrointestinal disorders Vomiting	14.2% 23/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	20.6% 33/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	17.4% 56/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Asthenia	4.9% 8/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	11.2% 18/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	8.1% 26/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Chills	7.4% 12/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	4.4% 7/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.9% 19/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Fatigue	23.5% 38/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	30.6% 49/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	27.0% 87/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Mucosal inflammation	3.1% 5/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	11.2% 18/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	7.1% 23/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Oedema peripheral	11.1% 18/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	11.2% 18/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	11.2% 36/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
General disorders Pyrexia	22.2% 36/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	28.7% 46/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	25.5% 82/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Immune system disorders Cytokine release syndrome	48.1% 78/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	0.00% 0/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	24.2% 78/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Immune system disorders Hypogammaglobulinaemia	9.9% 16/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	4.4% 7/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	7.1% 23/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Investigations Alanine aminotransferase increased	6.2% 10/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	6.9% 11/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	6.5% 21/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Investigations Blood creatinine increased	17.3% 28/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	17.5% 28/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	17.4% 56/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Investigations Aspartate aminotransferase increased	6.8% 11/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.0% 8/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.9% 19/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Investigations Blood alkaline phosphatase increased	0.62% 1/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	8.1% 13/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	4.3% 14/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Investigations C-reactive protein increased	5.6% 9/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	2.5% 4/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	4.0% 13/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Investigations Lymphocyte count decreased	3.7% 6/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.6% 9/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	4.7% 15/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Investigations Neutrophil count decreased	24.7% 40/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	17.5% 28/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	21.1% 68/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Investigations Platelet count decreased	22.2% 36/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	31.2% 50/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	26.7% 86/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Investigations White blood cell count decreased	11.1% 18/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	13.8% 22/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	12.4% 40/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Metabolism and nutrition disorders Decreased appetite	13.0% 21/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	10.6% 17/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	11.8% 38/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Psychiatric disorders Anxiety	6.2% 10/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.6% 9/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.9% 19/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Metabolism and nutrition disorders Hypocalcaemia	5.6% 9/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	6.2% 10/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.9% 19/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Metabolism and nutrition disorders Hypokalaemia	27.8% 45/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	30.0% 48/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	28.9% 93/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Metabolism and nutrition disorders Hypomagnesaemia	12.3% 20/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	18.1% 29/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	15.2% 49/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Metabolism and nutrition disorders Hyponatraemia	7.4% 12/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.6% 9/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	6.5% 21/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Metabolism and nutrition disorders Hypophosphataemia	8.0% 13/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	10.6% 17/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	9.3% 30/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 13/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	5.6% 9/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	6.8% 22/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.
Musculoskeletal and connective tissue disorders Back pain	9.3% 15/162 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	6.2% 10/160 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.	7.8% 25/322 • This primary analysis report includes data with a cut-off date 6-May-2021. Adverse Events (AEs) and death were collected from dose of study treatment to 56 days post last-infusion (defined as on-treatment) up to a max on-treatment period of approx. 2 years. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Other Adverse Event: An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect.