Trial Outcomes & Findings for Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant (NCT NCT03774082)

Last Updated: 2025-12-11

Results Overview

ORR is defined as the percentage of participants demonstrating a complete response (CR) or partial response (PR) without the requirement of additional systemic therapies for an earlier progression, mixed response or non-response. The response is assessed per National Institute of Health (NIH) consensus criteria and scoring of response was relative to the organ stage at the start of study treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

At Cycle 7 Day 1 (Day 168); Cycle = 28 Days

Results posted on

2025-12-11

Participant Flow

At least 5 evaluable participants per group were needed for the primary analysis in Groups 1, 2 and 3. No minimum number of evaluable participants were needed in Group 4. Disposition and Demographics are presented by age group.

Enrollment initiation into the youngest age group, Group 4, was subject to the availability of data in this age group from study CINC424F12201. However, no participants were enrolled in group 4 (aged ≥ 28 days to \< 2y) due to the completion of the overall study enrolment with participants in the older age groups (groups 1, 2, \& 3).

Participant milestones

Participant milestones
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) Participants received ruxolitinib 4mg/m2 orally twice a day (BID).
Overall Study STARTED	22	17	7
Overall Study Full Analysis Set	22	16	7
Overall Study Completed Treatment	3	5	3
Overall Study Discontinued From Treatment	19	11	4
Overall Study Participants Who Received Tablets	22	14	0
Overall Study Participants Who Received Liquid	0	2	7
Overall Study COMPLETED	14	10	4
Overall Study NOT COMPLETED	8	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) Participants received ruxolitinib 4mg/m2 orally twice a day (BID).
Overall Study Death	6	3	2
Overall Study Subject decision	0	3	0
Overall Study Lost to Follow-up	2	0	0
Overall Study Guardian decision	0	0	1
Overall Study Enrolled but received treatment beyond protocol requirement	0	1	0

Baseline Characteristics

Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=22 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) n=16 Participants Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) n=7 Participants Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	Total n=45 Participants Total of all reporting groups
Age, Continuous	175.2 months STANDARD_DEVIATION 20.05 • n=237 Participants	99.3 months STANDARD_DEVIATION 18.39 • n=243 Participants	47.1 months STANDARD_DEVIATION 15.08 • n=480 Participants	128.3 months STANDARD_DEVIATION 52.86 • n=639 Participants
Sex: Female, Male Female	7 Participants n=237 Participants	7 Participants n=243 Participants	2 Participants n=480 Participants	16 Participants n=639 Participants
Sex: Female, Male Male	15 Participants n=237 Participants	9 Participants n=243 Participants	5 Participants n=480 Participants	29 Participants n=639 Participants
Race/Ethnicity, Customized White	8 Participants n=237 Participants	10 Participants n=243 Participants	3 Participants n=480 Participants	21 Participants n=639 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=237 Participants	1 Participants n=243 Participants	0 Participants n=480 Participants	1 Participants n=639 Participants
Race/Ethnicity, Customized Asian	14 Participants n=237 Participants	5 Participants n=243 Participants	4 Participants n=480 Participants	23 Participants n=639 Participants

PRIMARY outcome

Timeframe: At Cycle 7 Day 1 (Day 168); Cycle = 28 Days

Population: Full Analysis Set (FAS) comprised all subjects to whom study treatment has been assigned and who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=22 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) n=16 Participants Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) n=7 Participants Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants n=45 Participants All participants from Group 1, Group 2 and Group 3.
Overall Response Rate (ORR) at Cycle 7 Day 1	36.4 Percentage of participants Interval 19.6 to 56.1	50.0 Percentage of participants Interval 27.9 to 72.1	28.6 Percentage of participants Interval 5.3 to 65.9	40.0 Percentage of participants Interval 27.7 to 53.3

SECONDARY outcome

Timeframe: Cycle 1 Day 1: 0.5, 2 and 6 hours post-dose; Pre-dose on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 3 Day 1, Cycle 5 Day 1 and Cycle 7 Day 1; Cycle = 28 Days

Population: The Pharmacokinetic Analysis Set (PAS) included all subjects who provided at least one evaluable PK concentration. Evaluable PK concentration: Participants took the dose of ruxolitinib prior to PK sample; For post-dose samples on Cycle 1 Day 1: participants did not vomit within 2 hours after dosing with ruxolitinib; For pre-dose samples: participant samples were collected before the next dose administration of ruxolitinib.

Pharmacokinetics (PK) of ruxolitinib by age groups (and formulation tablet vs liquid).

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=21 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) n=13 Participants Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) n=2 Participants Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants n=7 Participants All participants from Group 1, Group 2 and Group 3.
Ruxolitinib Concentrations by Timepoint Cycle 5 Day 1: 0 hr (pre-dose	13.0 ug/ml Geometric Coefficient of Variation 176.6	16.4 ug/ml Geometric Coefficient of Variation 470.7	11.0 ug/ml Geometric Coefficient of Variation 83.5	7.32 ug/ml Geometric Coefficient of Variation 102.0
Ruxolitinib Concentrations by Timepoint Cycle 7 Day 1: 0 hr (pre-dose	14.3 ug/ml Geometric Coefficient of Variation 173.7	10.7 ug/ml Geometric Coefficient of Variation 129.9	5.79 ug/ml Geometric Coefficient of Variation 120.1	4.94 ug/ml Geometric Coefficient of Variation 165.9
Ruxolitinib Concentrations by Timepoint Cycle 1 Day 22: 0 hr (pre-dose)	20.8 ug/ml Geometric Coefficient of Variation 199.5	11.7 ug/ml Geometric Coefficient of Variation 165.4	4.89 ug/ml Geometric Coefficient of Variation 505.2	10.3 ug/ml Geometric Coefficient of Variation 150.4
Ruxolitinib Concentrations by Timepoint Cycle 3 Day 1: 0 hr (pre-dose	11.4 ug/ml Geometric Coefficient of Variation 193.8	11.3 ug/ml Geometric Coefficient of Variation 193.1	2.66 ug/ml Geometric Coefficient of Variation 587.5	5.56 ug/ml Geometric Coefficient of Variation 180.8
Ruxolitinib Concentrations by Timepoint Cycle 1 Day 1: 0.5 hour (hr) (post-dose)	60.0 ug/ml Geometric Coefficient of Variation 350.7	32.4 ug/ml Geometric Coefficient of Variation 471.9	78.6 ug/ml	60.1 ug/ml Geometric Coefficient of Variation 98.7
Ruxolitinib Concentrations by Timepoint Cycle 1 Day 1: 2 hr (post-dose)	112 ug/ml Geometric Coefficient of Variation 51.8	106 ug/ml Geometric Coefficient of Variation 39.2	77.0 ug/ml	49.7 ug/ml Geometric Coefficient of Variation 30.7
Ruxolitinib Concentrations by Timepoint Cycle 1 Day 1: 6hr (post-dose)	56.7 ug/ml Geometric Coefficient of Variation 73.9	47.8 ug/ml Geometric Coefficient of Variation 164.1	60.0 ug/ml	15.3 ug/ml Geometric Coefficient of Variation 66.2
Ruxolitinib Concentrations by Timepoint Cycle 1 Day 8: 0 hr (pre-dose)	16.7 ug/ml Geometric Coefficient of Variation 208.3	10.9 ug/ml Geometric Coefficient of Variation 146.5	3.47 ug/ml	3.88 ug/ml Geometric Coefficient of Variation 152.4
Ruxolitinib Concentrations by Timepoint Cycle 1 Day 15: 0 hr (pre-dose)	17.8 ug/ml Geometric Coefficient of Variation 195.5	12.9 ug/ml Geometric Coefficient of Variation 248.2	4.14 ug/ml Geometric Coefficient of Variation 399.3	9.43 ug/ml Geometric Coefficient of Variation 121.5

SECONDARY outcome

Timeframe: From baseline up to 39 cycles; Cycle = 28 Days

Population: FAS comprised all subjects to whom study treatment has been assigned and who received at least one dose of study treatment. Duration of response (DOR) is assessed for responders only.

Time from first response until chronic Graft vs. host disease (cGvHD) progression, death, or the date of addition of systemic therapies for cGvHD assessed for responders only based on BOR up to Cycle 7 Day 1. Presented as percentage of participants to still be in response at different time points in months (per Kaplan-Meier estimates). Participants without event will be censored at the date of their last response assessment prior to or at the analysis cut-off date if no events occurred on or before 12 weeks (84 days) after the last GvHD assessment. As planned in the SAP, this outcome measure is provided for all participants instead of per age groups.

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=37 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants All participants from Group 1, Group 2 and Group 3.
Duration of Response (DOR) Month 1	94.59 Percentage of participants Interval 80.07 to 98.62	—	—	—
Duration of Response (DOR) Month 2	86.23 Percentage of participants Interval 70.01 to 94.03	—	—	—
Duration of Response (DOR) Month 6	74.24 Percentage of participants Interval 56.17 to 85.74	—	—	—
Duration of Response (DOR) Month 12	63.10 Percentage of participants Interval 43.74 to 77.38	—	—	—
Duration of Response (DOR) Month 18	58.89 Percentage of participants Interval 39.23 to 74.12	—	—	—
Duration of Response (DOR) Month 24	58.89 Percentage of participants Interval 39.23 to 74.12	—	—	—
Duration of Response (DOR) Month 30	58.89 Percentage of participants Interval 39.23 to 74.12	—	—	—
Duration of Response (DOR) Month 36	58.89 Percentage of participants Interval 39.23 to 74.12	—	—	—

SECONDARY outcome

Timeframe: At Cycle 4 Day 1 (Day 84); Cycle = 28 Days

Population: FAS comprised all subjects to whom study treatment has been assigned and who received at least one dose of study treatment.

ORR is defined as the percentage of participants demonstrating a complete response (CR) or partial response (PR) without the requirement of additional systemic therapies for an earlier progression, mixed response or non-response. The response is assessed per National Institute of Health (NIH) consensus criteria and scoring of response will be relative to the organ stage at the start of study treatment at Cycle 4 Day 1.

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=22 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) n=16 Participants Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) n=7 Participants Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants n=45 Participants All participants from Group 1, Group 2 and Group 3.
Overall Response Rate (ORR) at Cycle 4 Day 1	54.5 Percentage of participants Interval 35.3 to 72.9	62.5 Percentage of participants Interval 39.1 to 82.2	42.9 Percentage of participants Interval 12.9 to 77.5	55.6 Percentage of participants Interval 42.3 to 68.3

SECONDARY outcome

Timeframe: Until Cycle 7 Day 1 (Day 168) or the start of additional systemic therapy for cGvHD; Cycle = 28 Days

Population: FAS comprised all subjects to whom study treatment has been assigned and who received at least one dose of study treatment.

Percentage of participants who achieved overall response (complete response (CR) or partial response (PR)) at any time point until Cycle 7 Day 1 or the start of additional systemic therapy for chronic GvHD.

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=22 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) n=16 Participants Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) n=7 Participants Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants n=45 Participants All participants from Group 1, Group 2 and Group 3.
Best Overall Response (BOR)	81.8 Percentage of participants Interval 63.1 to 93.5	81.3 Percentage of participants Interval 58.3 to 94.7	85.7 Percentage of participants Interval 47.9 to 99.3	82.2 Percentage of participants Interval 70.2 to 90.8

SECONDARY outcome

Timeframe: From baseline up to 39 cycles; Cycle = 28 Days

Population: FAS comprised all subjects to whom study treatment has been assigned and who received at least one dose of study treatment.

Failure-free survival was defined as the time from date of treatment to any of the following events: i) relapse or recurrence of underlying disease or death due to underlying disease, ii) non-relapse mortality, or iii) addition or initiation of another systemic therapy for cGvHD per Kaplan-Meier estimates. As planned in the SAP, this outcome measure is provided for all participants instead of per age groups.

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=45 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants All participants from Group 1, Group 2 and Group 3.
Failure Free Survival (FFS) Month 1	91.11 Percentage of participants Interval 78.03 to 96.57	—	—	—
Failure Free Survival (FFS) Month 2	84.44 Percentage of participants Interval 70.12 to 92.26	—	—	—
Failure Free Survival (FFS) Month 6	68.89 Percentage of participants Interval 53.2 to 80.25	—	—	—
Failure Free Survival (FFS) Month 12	64.44 Percentage of participants Interval 48.67 to 76.48	—	—	—
Failure Free Survival (FFS) Month 18	57.78 Percentage of participants Interval 42.11 to 70.61	—	—	—
Failure Free Survival (FFS) Month 24	57.78 Percentage of participants Interval 42.11 to 70.61	—	—	—
Failure Free Survival (FFS) Month 30	57.78 Percentage of participants Interval 42.11 to 70.61	—	—	—
Failure Free Survival (FFS) Month 36	57.78 Percentage of participants Interval 42.11 to 70.61	—	—	—

SECONDARY outcome

Timeframe: From baseline up to 39 cycles; Cycle = 28 Days

Population: FAS comprised all subjects to whom study treatment has been assigned and who received at least one dose of study treatment, assessed for subjects with malignancy relapse/occurrence only.

MR was defined as the time from date of treatment assignment to the date of hematologic malignancy relapse/recurrence. Calculated for subjects with underlying hematologic malignant disease. The cumulative incidence (CI) of malignancy relapse/recurrence at 1, 2, 6, 12, 18, 24, 30 and 36 months after start of treatment has been reported. As planned in the SAP, this outcome measure is provided for all participants instead of per age groups.

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=30 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants All participants from Group 1, Group 2 and Group 3.
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) Month 1	3.33 Percentage of participants Interval 0.23 to 14.8	—	—	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) Month 2	10.00 Percentage of participants Interval 2.47 to 23.88	—	—	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) Month 6	10.00 Percentage of participants Interval 2.47 to 23.88	—	—	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) Month 12	10.00 Percentage of participants Interval 2.47 to 23.88	—	—	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) Month 18	10.00 Percentage of participants Interval 2.47 to 23.88	—	—	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) Month 24	10.00 Percentage of participants Interval 2.47 to 23.88	—	—	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) Month 30	10.00 Percentage of participants Interval 2.47 to 23.88	—	—	—
Cumulative Incidence of Malignancy Relapse/Recurrence (MR) Month 36	10.00 Percentage of participants Interval 2.47 to 23.88	—	—	—

SECONDARY outcome

Timeframe: From baseline up to 39 cycles; Cycle = 28 Days

Population: FAS comprised all subjects to whom study treatment has been assigned and who received at least one dose of study treatment.

NRM is defined as the time from date of treatment assignment to date of death not preceded by underlying disease relapse/recurrence calculated for all participants. The cumulative incidence (CI) of non-relapse mortality at 1, 2, 6, 12, 18, 24, 30 and 36 months after start of treatment has been reported. As planned in the SAP, this outcome measure is provided for all participants instead of per age groups.

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=45 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants All participants from Group 1, Group 2 and Group 3.
Non-relapse Mortality (NRM) Month 1	2.22 Percentage of participants Interval 0.17 to 10.28	—	—	—
Non-relapse Mortality (NRM) Month 2	2.22 Percentage of participants Interval 0.17 to 10.28	—	—	—
Non-relapse Mortality (NRM) Month 6	6.67 Percentage of participants Interval 1.7 to 16.53	—	—	—
Non-relapse Mortality (NRM) Month 12	13.33 Percentage of participants Interval 5.34 to 25.02	—	—	—
Non-relapse Mortality (NRM) Month 18	17.78 Percentage of participants Interval 8.23 to 30.28	—	—	—
Non-relapse Mortality (NRM) Month 24	20.07 Percentage of participants Interval 9.8 to 32.93	—	—	—
Non-relapse Mortality (NRM) Month 30	20.07 Percentage of participants Interval 9.8 to 32.93	—	—	—
Non-relapse Mortality (NRM) Month 36	20.07 Percentage of participants Interval 9.8 to 32.93	—	—	—

SECONDARY outcome

Timeframe: From baseline up to 39 cycles; Cycle = 28 Days

Population: FAS comprised all subjects to whom study treatment has been assigned and who received at least one dose of study treatment.

OS is defined as the time from the date of treatment assignment to the date of death due to any cause. As planned in the SAP, this outcome measure is provided for all participants instead of per age groups.

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=45 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants All participants from Group 1, Group 2 and Group 3.
Overall Survival (OS) Month 1	97.78 survival probability in percentage Interval 85.25 to 99.68	—	—	—
Overall Survival (OS) Month 2	97.78 survival probability in percentage Interval 85.25 to 99.68	—	—	—
Overall Survival (OS) Month 6	91.06 survival probability in percentage Interval 77.9 to 96.55	—	—	—
Overall Survival (OS) Month 12	84.23 survival probability in percentage Interval 69.73 to 92.15	—	—	—
Overall Survival (OS) Month 18	79.67 survival probability in percentage Interval 64.57 to 88.87	—	—	—
Overall Survival (OS) Month 24	77.33 survival probability in percentage Interval 61.94 to 87.11	—	—	—
Overall Survival (OS) Month 30	77.33 survival probability in percentage Interval 61.94 to 87.11	—	—	—
Overall Survival (OS) Month 36	74.91 survival probability in percentage Interval 59.26 to 85.26	—	—	—

SECONDARY outcome

Timeframe: Baseline to Cycle 7 Day 1 (Day 168); Cycle = 28 Days

Population: FAS comprised all subjects to whom study treatment has been assigned and who received at least one dose of study treatment and received corticosteroids at baseline.

Reduction of at least ≥50% from baseline in daily corticosteroid use by Cycle 7 Day 1 (regardless of reason). As planned in the SAP, this outcome measure is provided for all participants instead of per age groups, for those who received corticosteroids at baseline.

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=40 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants All participants from Group 1, Group 2 and Group 3.
Percentage of Participants With ≥50% Reduction From Baseline in Daily Corticosteroid Dose	75.0 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline to Cycle 7 Day 1 (Day 168); Cycle = 28 Days

Population: FAS comprised all subjects to whom study treatment has been assigned and who received at least one dose of study treatment and received corticosteroids at baseline.

Reduction to low dose corticosteroids, is defined as the percentage of participants with reduction from baseline in daily corticosteroid dose to methylprednisolone-equivalent steroid dose of ≤ 0.2 mg/kg/day (or equivalent dose of ≤ 0.25 mg/kg/day prednisone or prednisolone). As planned in the SAP, this outcome measure is provided for all participants instead of per age groups, for those who received corticosteroids at baseline.

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=40 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants All participants from Group 1, Group 2 and Group 3.
Percentage of Participants With a Reduction to a Low Dose Corticosteriod	67.5 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: From baseline up to 39 cycles; Cycle = 28 Days

Population: FAS comprised all subjects to whom study treatment has been assigned and who received at least one dose of study treatment. As planned in the SAP, this outcome measure is provided for all participants instead of per age groups.

Reported are the number of participants with graft failure from all age groups together. Graft failure was assessed by donor cell chimerism, defined as initial whole blood or marrow donor chimerism for those who had ≥ 5% donor cell chimerism at baseline. If donor cell chimerism declined to \< 5% on subsequent measurements, graft failure was declared. As planned in the SAP, this outcome measure is provided for all participants instead of per age groups.

Outcome measures

Outcome measures
Measure	≥ 12y - < 18y RUX 10mg BID (Group 1) n=45 Participants Participants received ruxolitinib 10mg orally twice a day (BID).	≥ 6y - < 12y RUX 5mg BID (Group 2) Participants received ruxolitinib 5mg orally twice a day (BID).	≥ 2y - < 6y RUX 4mg/m2 BID (Group 3) Participants received ruxolitinib 4mg/m2 orally twice a day (BID).	All Participants All participants from Group 1, Group 2 and Group 3.
Graft Failure	2 Participants	—	—	—

Adverse Events

On-Treatment >=12y - <18y RUX 10mg BID

Serious events: 15 serious events

Other events: 22 other events

Deaths: 0 deaths

On-Treatment >=6y - <12y RUX 5mg BID

Serious events: 7 serious events

Other events: 15 other events

Deaths: 2 deaths

On-Treatment >=2y - <6y RUX 4mg/m2 BID

Serious events: 4 serious events

Other events: 7 other events

Deaths: 1 deaths

On-Treatment - All Participants

Serious events: 26 serious events

Other events: 44 other events

Deaths: 3 deaths

Post-Treatment >=12y - <18y RUX 10mg BID

Serious events: 3 serious events

Other events: 4 other events

Deaths: 6 deaths

Post-Treatment >=6y - <12y RUX 5mg BID

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Post-Treatment >=2y - <6y RUX 4mg/m2 BID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Post-Treatment All Participants

Serious events: 3 serious events

Other events: 6 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	On-Treatment >=12y - <18y RUX 10mg BID n=22 participants at risk On-treatment period: from first dose of study treatment up to 30 days post-treatment.	On-Treatment >=6y - <12y RUX 5mg BID n=16 participants at risk On-treatment period: from first dose of study treatment up to 30 days post-treatment.	On-Treatment >=2y - <6y RUX 4mg/m2 BID n=7 participants at risk On-treatment period: from first dose of study treatment up to 30 days post-treatment.	On-Treatment - All Participants n=45 participants at risk All participants from Group 1, Group 2 and Group 3.	Post-Treatment >=12y - <18y RUX 10mg BID n=22 participants at risk Events collected in the post- treatment survival follow-up phase (starting from day 31 post- treatment).	Post-Treatment >=6y - <12y RUX 5mg BID n=16 participants at risk Events collected in the post- treatment survival follow-up phase (starting from day 31 post- treatment).	Post-Treatment >=2y - <6y RUX 4mg/m2 BID n=7 participants at risk Events collected in the post- treatment survival follow-up phase (starting from day 31 post- treatment).	Post-Treatment All Participants n=45 participants at risk All participants from Group 1, Group 2 and Group 3.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Blood and lymphatic system disorders Thrombocytopenia	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Cardiac disorders Bradycardia	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Eye disorders Retinal vein occlusion	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Gastrointestinal disorders Pneumatosis intestinalis	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
General disorders Oedema peripheral	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
General disorders Pyrexia	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Immune system disorders Haemophagocytic lymphohistiocytosis	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Aspergillus infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations COVID-19	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Cytomegalovirus infection reactivation	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Dengue fever	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Epstein-Barr virus infection	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Gastroenteritis viral	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Herpes zoster	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Human bocavirus infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Infectious pleural effusion	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Parainfluenzae virus infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Pneumonia	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Pneumonia fungal	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Pneumonia respiratory syncytial viral	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Pneumonia viral	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Rhinovirus infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Sepsis	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Septic shock	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Tooth infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Upper respiratory tract infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Urinary tract infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Injury, poisoning and procedural complications Transfusion-related acute lung injury	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Injury, poisoning and procedural complications Transplant failure	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Blood creatinine increased	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Hyponatraemia	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Steroid diabetes	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Musculoskeletal and connective tissue disorders Muscular weakness	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Musculoskeletal and connective tissue disorders Pain in extremity	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post transplant lymphoproliferative disorder	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Nervous system disorders Aura	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Nervous system disorders Presyncope	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Renal and urinary disorders Urinary retention	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Alveolar proteinosis	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.

Other adverse events

Other adverse events
Measure	On-Treatment >=12y - <18y RUX 10mg BID n=22 participants at risk On-treatment period: from first dose of study treatment up to 30 days post-treatment.	On-Treatment >=6y - <12y RUX 5mg BID n=16 participants at risk On-treatment period: from first dose of study treatment up to 30 days post-treatment.	On-Treatment >=2y - <6y RUX 4mg/m2 BID n=7 participants at risk On-treatment period: from first dose of study treatment up to 30 days post-treatment.	On-Treatment - All Participants n=45 participants at risk All participants from Group 1, Group 2 and Group 3.	Post-Treatment >=12y - <18y RUX 10mg BID n=22 participants at risk Events collected in the post- treatment survival follow-up phase (starting from day 31 post- treatment).	Post-Treatment >=6y - <12y RUX 5mg BID n=16 participants at risk Events collected in the post- treatment survival follow-up phase (starting from day 31 post- treatment).	Post-Treatment >=2y - <6y RUX 4mg/m2 BID n=7 participants at risk Events collected in the post- treatment survival follow-up phase (starting from day 31 post- treatment).	Post-Treatment All Participants n=45 participants at risk All participants from Group 1, Group 2 and Group 3.
Eye disorders Dry eye	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Eye disorders Glaucoma	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Eye disorders Ocular hyperaemia	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Gastrointestinal disorders Abdominal pain	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	8.9% 4/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Gastrointestinal disorders Constipation	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Gastrointestinal disorders Dental caries	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Blood and lymphatic system disorders Anaemia	31.8% 7/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	28.6% 2/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	24.4% 11/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Blood and lymphatic system disorders Leukopenia	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Blood and lymphatic system disorders Neutropenia	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	25.0% 4/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	28.6% 2/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	17.8% 8/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Blood and lymphatic system disorders Thrombocytopenia	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	11.1% 5/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Cardiac disorders Tachycardia	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	8.9% 4/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Ear and labyrinth disorders Ear canal stenosis	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Ear and labyrinth disorders Ear pain	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Endocrine disorders Cushing's syndrome	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Eye disorders Astigmatism	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Eye disorders Blepharitis	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Eye disorders Cataract	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Eye disorders Conjunctivitis allergic	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	8.9% 4/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Gastrointestinal disorders Diarrhoea	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	11.1% 5/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Gastrointestinal disorders Lip pain	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Gastrointestinal disorders Vomiting	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	11.1% 5/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
General disorders Influenza like illness	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
General disorders Oedema peripheral	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
General disorders Pain	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
General disorders Pyrexia	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	25.0% 4/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	15.6% 7/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Hepatobiliary disorders Jaundice	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Hepatobiliary disorders Liver disorder	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Immune system disorders Allergy to chemicals	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Acarodermatitis	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Aspergillus infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations BK virus infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Bronchiolitis	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations COVID-19	18.2% 4/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	18.8% 3/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	28.6% 2/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	20.0% 9/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Conjunctivitis	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	8.9% 4/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Cytomegalovirus infection reactivation	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	8.9% 4/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Epstein-Barr viraemia	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Fungal skin infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Gastroenteritis	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Gastroenteritis viral	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Influenza	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	8.9% 4/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Lower respiratory tract infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Nasopharyngitis	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	18.8% 3/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	11.1% 5/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Onychomycosis	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Oral viral infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Otitis media	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Parainfluenzae virus infection	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Pneumonia	18.2% 4/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	11.1% 5/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Rhinovirus infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Skin infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Streptococcal infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Tonsillitis	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Upper respiratory tract infection	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	25.0% 4/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	57.1% 4/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	20.0% 9/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Urinary tract infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Infections and infestations Viral infection	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Injury, poisoning and procedural complications Extraskeletal ossification	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Injury, poisoning and procedural complications Fall	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Injury, poisoning and procedural complications Head injury	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Alanine aminotransferase increased	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	11.1% 5/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Amylase increased	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Aspartate aminotransferase increased	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Blood alkaline phosphatase increased	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Blood cholesterol increased	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Blood creatine phosphokinase increased	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Blood lactate dehydrogenase increased	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Blood magnesium increased	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations C-reactive protein increased	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Epstein-Barr virus test positive	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Gamma-glutamyltransferase increased	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Hepatic enzyme increased	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Herpes simplex test positive	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Immunoglobulins decreased	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Lymphocyte count decreased	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Neutrophil count decreased	22.7% 5/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	28.6% 2/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	20.0% 9/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Platelet count decreased	22.7% 5/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	15.6% 7/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Serum ferritin increased	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Vascular access device culture positive	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Weight decreased	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations Weight increased	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Investigations White blood cell count decreased	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	11.1% 5/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Hypercholesterolaemia	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Hyperkalaemia	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Hypoglycaemia	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Hypokalaemia	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Hypomagnesaemia	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	8.9% 4/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Hypophosphataemia	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Hypozincaemia	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Obesity	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Steroid diabetes	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Metabolism and nutrition disorders Vitamin D deficiency	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Musculoskeletal and connective tissue disorders Arthralgia	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Musculoskeletal and connective tissue disorders Back pain	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	8.9% 4/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Musculoskeletal and connective tissue disorders Bone pain	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Musculoskeletal and connective tissue disorders Knee deformity	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Musculoskeletal and connective tissue disorders Osteoporosis	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Musculoskeletal and connective tissue disorders Pain in extremity	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Nervous system disorders Headache	22.7% 5/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	15.6% 7/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Nervous system disorders Polyneuropathy	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Psychiatric disorders Insomnia	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Reproductive system and breast disorders Acquired phimosis	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Reproductive system and breast disorders Pruritus genital	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Cough	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	18.8% 3/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	13.3% 6/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Productive cough	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Acne	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Dry skin	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Eczema	9.1% 2/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	8.9% 4/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Erythema	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.7% 3/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Hypertrichosis	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Pruritus	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	6.2% 1/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Rash	4.5% 1/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	12.5% 2/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	4.4% 2/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Vascular disorders Hot flush	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	2.2% 1/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.
Vascular disorders Hypertension	13.6% 3/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	18.8% 3/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	14.3% 1/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	15.6% 7/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/22 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/16 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/7 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.	0.00% 0/45 • Adverse events (AEs) and on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. Post-treatment survival follow-up deaths were collected 31 days after last dose of study medication until the end of the study, up to approx. 36 months/39 cycles. An Adverse Event (AE) is any sign or symptom that occurs during the conduct of the trial and post-treatment survival follow-up.

Additional Information

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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.
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