Trial Outcomes & Findings for A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT01611090)

NCT ID: NCT01611090

Last Updated: 2020-03-03

Results Overview

PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); \>=50% increase in existing lymph nodes; \>=50% increase in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (and to \>=5\*10\^9/L) or \>=50% increase from nadir count confirmed on \>=2 serial assessments if absolute lymphocyte count (ALC) \>=30,000 per microliter and lymphocyte doubling time is rapid, unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b \[Hgb\] or platelets) attributable to CLL; and transformation to a more aggressive histology.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 578 participants
• Primary outcome timeframe: Up to 5 years
• Results posted on: 2020-03-03

Participant Flow

A total of 578 participants were enrolled in the study. Among these, 289 participants were randomized in each ibrutinib + bendamustine/rituximab (BR) treatment group and placebo+BR treatment group.

Participant milestones

Measure	Ibrutinib+BR Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.	Crossover to Ibrutinib Participants in the placebo+BR treatment group could cross over to receive next-line ibrutinib treatment (420 mg \[3 \* 140 mg capsules\] orally once daily on a 28-day cycle) at the discretion of the investigator at the time of disease progression or if International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for treatment were met.
Randomized Period STARTED	289	289	0
Randomized Period Treated	287	287	0
Randomized Period COMPLETED	259	260	0
Randomized Period NOT COMPLETED	30	29	0
Cross Over (Placebo to Ibrutinib) STARTED	0	0	183
Cross Over (Placebo to Ibrutinib) Treated	0	0	183
Cross Over (Placebo to Ibrutinib) COMPLETED	0	0	178
Cross Over (Placebo to Ibrutinib) NOT COMPLETED	0	0	5

Reasons for withdrawal

Measure	Ibrutinib+BR Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.	Crossover to Ibrutinib Participants in the placebo+BR treatment group could cross over to receive next-line ibrutinib treatment (420 mg \[3 \* 140 mg capsules\] orally once daily on a 28-day cycle) at the discretion of the investigator at the time of disease progression or if International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for treatment were met.
Randomized Period Lost to Follow-up	8	3	0
Randomized Period Withdrawal by Subject	22	26	0
Cross Over (Placebo to Ibrutinib) Lost to Follow-up	0	0	4
Cross Over (Placebo to Ibrutinib) Withdrawal by Subject	0	0	1

Baseline Characteristics

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Baseline characteristics by cohort

Measure	Ibrutinib+BR n=289 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=289 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.	Total n=578 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 9.82 • n=5 Participants	63.3 years STANDARD_DEVIATION 9.3 • n=7 Participants	63.5 years STANDARD_DEVIATION 9.56 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	100 Participants n=7 Participants	196 Participants n=5 Participants
Sex: Female, Male Male	193 Participants n=5 Participants	189 Participants n=7 Participants	382 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	21 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	256 Participants n=5 Participants	253 Participants n=7 Participants	509 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized White	264 Participants n=5 Participants	264 Participants n=7 Participants	528 Participants n=5 Participants
Race/Ethnicity, Customized Black	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or not reported	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment ARGENTINA	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment BELGIUM	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment BRAZIL	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment CANADA	27 Participants n=5 Participants	35 Participants n=7 Participants	62 Participants n=5 Participants
Region of Enrollment COLOMBIA	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment CZECH REPUBLIC	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment FRANCE	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment GERMANY	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment GREECE	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment ISRAEL	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment MEXICO	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment POLAND	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment PORTUGAL	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment RUSSIAN FEDERATION	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Region of Enrollment SOUTH KOREA	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment SPAIN	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment SWEDEN	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment TURKEY	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment UKRAINE	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment UNITED KINGDOM	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment UNITED STATES	38 Participants n=5 Participants	26 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.

PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); >=50% increase in existing lymph nodes; >=50% increase in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) or >=50% increase from nadir count confirmed on >=2 serial assessments if absolute lymphocyte count (ALC) >=30,000 per microliter and lymphocyte doubling time is rapid, unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b [Hgb] or platelets) attributable to CLL; and transformation to a more aggressive histology.

Outcome measures

Measure	Ibrutinib+BR n=289 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=289 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Progression-free Survival (PFS)	65.12 Months Interval 55.43 to Here, NA indicates upper limit of confidence interval (CI) was not estimable due to insufficient number of events.	14.32 Months Interval 13.86 to 16.62

SECONDARY outcome

Timeframe: Up to 5 years

Population: Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.

ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL) and absolute lymphocyte count <4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR-2 of the following when abnormal at baseline: >=50% decrease in ALC, >=50% decrease in sum products of up to 6 lymph nodes, >=50% decrease in enlargement of spleen or liver; and 1 of the following: neutrophils >1.5*10^9/L, Platelets >100*10^9/L and Hgb>11 g/dL or >=50% improvement over baseline in any of these; no new enlarged nodes or new hepatosplenomegaly.

Outcome measures

Measure	Ibrutinib+BR n=289 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=289 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Overall Response Rate (ORR)	87.2 Percentage of participants	66.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.

OS was defined as the interval between the date of randomization and the date of death from any cause.

Outcome measures

Measure	Ibrutinib+BR n=289 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=289 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Overall Survival (OS)	NA Months Interval 70.93 to Here, NA indicates median and upper limit of CI was not estimable due to insufficient number of events.	NA Months Here, NA indicates median and CI was not estimable due to insufficient number of events.

SECONDARY outcome

Timeframe: Up to 5 years

Population: Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.

MRD-negative response was defined as the percentage of participants who reach MRD negative disease status (less than 1 chronic lymphocytic leukemia [CLL] cell per 10,000 leukocytes) in either bone marrow or peripheral blood. All randomized participants were included in this analysis. Participants with missing MRD data were considered non-responders.

Outcome measures

Measure	Ibrutinib+BR n=289 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=289 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Percentage of Participants With Minimal Residual Disease (MRD)-Negative Response	28.7 Percentage of participants	5.9 Percentage of participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: ITT population included all participants randomized into the study regardless of treatment actually received.

Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (>)100* 109/liter (L) if baseline less than or equal to (<=) 100*109/L or increase >= 50 percent (%) over baseline; 2) Hemoglobin >11 gram per deciliters (g/dL) if baseline <= 11 g/dL or increase >= 2 g/dL over baseline.

Outcome measures

Measure	Ibrutinib+BR n=289 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=289 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Percentage of Participants With Sustained Hematologic Improvement Hemoglobin	36.7 Percentage of Participants	29.1 Percentage of Participants
Percentage of Participants With Sustained Hematologic Improvement Platelets	30.8 Percentage of Participants	21.8 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: ITT population included all participants randomized into the study regardless of treatment actually received.

Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).

Outcome measures

Measure	Ibrutinib+BR n=289 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=289 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Median Time to Clinically Meaningful Improvement in FACIT-Fatigue Scale	6.5 Months Interval 4.7 to 10.7	4.6 Months Interval 2.8 to 6.4

SECONDARY outcome

Timeframe: From the date of randomization to disease progression (Up to 2 years)

Population: ITT population included all participants randomized into the study regardless of treatment actually received.

The disease-related symptoms included fatigue, weight loss, fevers, night sweats, abdominal discomfort/splenomegaly and anorexia.

Outcome measures

Measure	Ibrutinib+BR n=289 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=289 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.

Number of participants who received subsequent antineoplastic therapy was reported.

Outcome measures

Measure	Ibrutinib+BR n=287 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=287 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Number of Participants Who Received Subsequent Antineoplastic Therapy	52 Participants	61 Participants

SECONDARY outcome

Timeframe: Baseline to EOT (Up to 2 years)

Population: ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.

Change from baseline in beta2 microglobulin at end of treatment at time of primary analysis was reported.

Outcome measures

Measure	Ibrutinib+BR n=39 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=106 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Change From Baseline in Beta2 Microglobulin at End of Treatment (EOT)	-0.46 milligram per liter (mg/L) Standard Deviation 1.77	-0.23 milligram per liter (mg/L) Standard Deviation 2.08

SECONDARY outcome

Timeframe: Baseline to EOT (up to 2 years)

Population: ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.

FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).

Outcome measures

Measure	Ibrutinib+BR n=38 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=104 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Change From Baseline in FACIT-Fatigue Scale at End of Treatment	-0.9 Units on a scale Standard Deviation 11.22	0.0 Units on a scale Standard Deviation 11.01

SECONDARY outcome

Timeframe: Baseline to EOT (up to 2 years)

Population: ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.

EORTC QLQ-C30 Physical Functioning Score is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which was rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. All scale and item scores were linearly transformed to be in range from 0-100. A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms.

Outcome measures

Measure	Ibrutinib+BR n=38 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=104 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score at End of Treatment	-2.1 Units on a scale Standard Deviation 16.34	-4.1 Units on a scale Standard Deviation 22.52

SECONDARY outcome

Timeframe: Baseline to EOT (up to 2 years)

Population: ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint. Here, 'n' signifies the number of participants analyzed for the specified symptoms.

The EORTC QLQ-CLL 16 is a 16-item disease specific module that comprises 5 domains of patient-reported health status important in CLL. There are three multi-item scales that include fatigue (2 items), treatment side effects and disease symptoms (8 items), and infection (4 items), and 2 single-item scales on social activities and future health worries. Responses are measured on a 4 point scale ranging from 1 (not at all) to 4 (very much).

Outcome measures

Measure	Ibrutinib+BR n=38 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=104 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Lost weight	0.1 Units on the scale Standard Deviation 0.86	0.0 Units on the scale Standard Deviation 0.74
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Dry mouth	0.3 Units on the scale Standard Deviation 0.96	0.1 Units on the scale Standard Deviation 0.85
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Bruises	0.1 Units on the scale Standard Deviation 0.61	0.0 Units on the scale Standard Deviation 0.65
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Abdominal discomfort	0.1 Units on the scale Standard Deviation 0.81	0.0 Units on the scale Standard Deviation 0.76
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Temperature going up and down	0.1 Units on the scale Standard Deviation 0.93	0.0 Units on the scale Standard Deviation 0.72
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Night sweats	-0.6 Units on the scale Standard Deviation 0.92	-0.3 Units on the scale Standard Deviation 1.07
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Skin problems	0.4 Units on the scale Standard Deviation 1.14	0.3 Units on the scale Standard Deviation 0.96
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Feel ill	0.1 Units on the scale Standard Deviation 1.08	0.2 Units on the scale Standard Deviation 0.98
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Feel lethargic	0.1 Units on the scale Standard Deviation 1.01	0.0 Units on the scale Standard Deviation 0.91
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Felt slowed down	0.3 Units on the scale Standard Deviation 0.80	0.0 Units on the scale Standard Deviation 0.97
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Limited in planning activities	0.2 Units on the scale Standard Deviation 0.97	0.1 Units on the scale Standard Deviation 0.90
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Worried about health in the future	0.0 Units on the scale Standard Deviation 0.94	0.0 Units on the scale Standard Deviation 0.97
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Trouble with chest infections	0.2 Units on the scale Standard Deviation 1.05	0.0 Units on the scale Standard Deviation 0.82
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Trouble with other infections	0.7 Units on the scale Standard Deviation 1.07	0.1 Units on the scale Standard Deviation 0.86
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Repeated courses of antibiotics	0.9 Units on the scale Standard Deviation 1.22	0.0 Units on the scale Standard Deviation 0.97
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment Worried about picking up infection	0.3 Units on the scale Standard Deviation 0.96	0.2 Units on the scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: Baseline to EOT (up to 2 years)

Population: ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.

The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health).

Outcome measures

Measure	Ibrutinib+BR n=38 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=110 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale at End of Treatment	-4.3 Units on a scale Standard Deviation 19.58	4.0 Units on a scale Standard Deviation 18.21

SECONDARY outcome

Timeframe: Baseline to EOT (up to 2 years)

Population: ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.

The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1. High score indicating a high level of utility.

Outcome measures

Measure	Ibrutinib+BR n=38 Participants Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=110 Participants Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Utility Score Scale at End of Treatment	0.0 Units on a scale Standard Deviation 0.28	0.0 Units on a scale Standard Deviation 0.24

Adverse Events

Ibrutinib+BR

Serious events: 198 serious events

Other events: 268 other events

Deaths: 74 deaths

Placebo+BR

Serious events: 127 serious events

Other events: 271 other events

Deaths: 107 deaths

Crossover to Ibrutinib

Serious events: 105 serious events

Other events: 157 other events

Deaths: 57 deaths

Serious adverse events

Measure	Ibrutinib+BR n=287 participants at risk Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=287 participants at risk Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.	Crossover to Ibrutinib n=183 participants at risk Participants in the placebo+BR treatment group could cross over to receive next-line ibrutinib treatment (420 mg \[3 \* 140 mg capsules\] orally once daily on a 28-day cycle) at the discretion of the investigator at the time of disease progression or if International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for treatment were met.
Blood and lymphatic system disorders Anaemia	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.4% 7/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Aplasia Pure Red Cell	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Aplastic Anaemia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Autoimmune Haemolytic Anaemia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.7% 5/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Bone Marrow Failure	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Cytopenia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Febrile Neutropenia	10.5% 30/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	7.7% 22/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Haemolytic Anaemia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Immune Thrombocytopenic Purpura	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Neutropenia	2.4% 7/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.1% 6/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Pancytopenia	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Thrombocytopenia	1.4% 4/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Acute Coronary Syndrome	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Angina Pectoris	1.4% 4/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Angina Unstable	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Arrhythmia Supraventricular	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Atrial Fibrillation	5.6% 16/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.3% 6/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Atrial Flutter	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Atrioventricular Block	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Cardiac Arrest	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Cardiac Failure	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Cardio-Respiratory Arrest	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Cardiopulmonary Failure	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Cardiovascular Insufficiency	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Carditis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Coronary Artery Occlusion	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Myocardial Infarction	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Myocarditis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Pericardial Effusion	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Sinus Node Dysfunction	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Sinus Tachycardia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Tachycardia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Ventricular Fibrillation	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Ventricular Flutter	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Ventricular Tachycardia	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Endocrine disorders Addison's Disease	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Endocrine disorders Goitre	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Eye disorders Cataract	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Eye disorders Maculopathy	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Eye disorders Retinal Haemorrhage	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Eye disorders Scleral Disorder	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Eye disorders Vitreous Adhesions	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Eye disorders Vitreous Haemorrhage	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Abdominal Hernia	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Abdominal Incarcerated Hernia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Abdominal Pain	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Anal Fistula	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Ascites	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Colitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Colitis Ischaemic	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Constipation	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Diarrhoea	1.4% 4/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Dyspepsia	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Dysphagia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Enterocolitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Gastric Haemorrhage	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Gastric Ulcer Perforation	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Gastritis	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Gastrointestinal Disorder	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Gastrointestinal Inflammation	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Haematemesis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Haematochezia	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Inguinal Hernia	1.4% 4/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Intra-Abdominal Haemorrhage	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Large Intestine Perforation	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Mouth Ulceration	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Nausea	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Oesophageal Ulcer	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Oesophagitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Pancreatitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Pancreatitis Acute	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Proctitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Small Intestinal Obstruction	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Stomatitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Volvulus	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Vomiting	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Asthenia	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Chest Pain	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Chills	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Complication Associated with Device	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Condition Aggravated	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Death	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Disease Progression	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Fatigue	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders General Physical Health Deterioration	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Hernia	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Influenza Like Illness	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Infusion Site Extravasation	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Malaise	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Mucosal Inflammation	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Multiple Organ Dysfunction Syndrome	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Non-Cardiac Chest Pain	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Oedema Peripheral	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Pneumatosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Pyrexia	3.8% 11/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.4% 7/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.2% 4/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Sudden Cardiac Death	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Sudden Death	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Systemic Inflammatory Response Syndrome	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Hepatobiliary disorders Cholangitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Hepatobiliary disorders Cholecystitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Hepatobiliary disorders Cholecystitis Chronic	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Hepatobiliary disorders Cholelithiasis	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Hepatobiliary disorders Cholestasis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Hepatobiliary disorders Gallbladder Obstruction	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Hepatobiliary disorders Hepatic Cirrhosis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Hepatobiliary disorders Hepatitis Toxic	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Hepatobiliary disorders Hepatocellular Injury	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Hepatobiliary disorders Hepatosplenomegaly	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Immune system disorders Anaphylactic Reaction	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Abscess Jaw	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Actinomycotic Pulmonary Infection	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Acute Sinusitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Appendicitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Arthritis Bacterial	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Ascariasis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Atypical Pneumonia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Bacteraemia	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Brain Abscess	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Breast Abscess	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Breast Cellulitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Bronchitis	2.8% 8/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.7% 5/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Bronchopulmonary Aspergillosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Campylobacter Infection	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Cellulitis	1.4% 4/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Cellulitis Staphylococcal	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Central Nervous System Infection	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Chronic Sinusitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Clostridium Difficile Colitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Clostridium Difficile Infection	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Conjunctivitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Cystitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Cytomegalovirus Colitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Cytomegalovirus Infection	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Dacryocystitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Dermo-Hypodermitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Disseminated Cryptococcosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Epstein-Barr Virus Infection	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Erysipelas	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Escherichia Sepsis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Escherichia Urinary Tract Infection	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Fungal Infection	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Gastroenteritis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Gastroenteritis Viral	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Gastrointestinal Infection	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Haemophilus Infection	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Hepatitis B Reactivation	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Herpes Zoster	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Infection	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Infectious Pleural Effusion	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Influenza	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Laryngitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Lung Infection	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Lymphadenitis Bacterial	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Muscle Abscess	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Neutropenic Sepsis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Nocardiosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Oral Candidiasis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Osteomyelitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Otitis Media	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Periodontitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Periorbital Cellulitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Peritonsillar Abscess	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pharyngeal Abscess	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pharyngitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pharyngitis Streptococcal	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pneumocystis Jirovecii Pneumonia	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pneumonia	16.7% 48/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	9.1% 26/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	18.6% 34/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pneumonia Bacterial	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pneumonia Haemophilus	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pneumonia Pneumococcal	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pneumonia Streptococcal	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Progressive Multifocal Leukoencephalopathy	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pseudomembranous Colitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pulmonary Tuberculoma	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pulmonary Tuberculosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pyelonephritis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Rash Pustular	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Respiratory Syncytial Virus Infection	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Respiratory Tract Infection	1.7% 5/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.7% 5/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Sepsis	2.8% 8/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.4% 4/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.2% 4/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Septic Shock	2.1% 6/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.7% 5/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Sinusitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Skin Candida	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Skin Infection	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Soft Tissue Infection	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Splenic Abscess	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Staphylococcal Infection	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Staphylococcal Skin Infection	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Subcutaneous Abscess	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Tooth Abscess	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Tuberculosis of Central Nervous System	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Upper Respiratory Tract Infection	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Urinary Tract Infection	2.1% 6/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Urosepsis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Varicella	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Varicella Zoster Virus Infection	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Viral Infection	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Abdominal Injury	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Ankle Fracture	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Fall	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Femur Fracture	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Hip Fracture	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Incision Site Haemorrhage	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Infusion Related Reaction	1.4% 4/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.7% 5/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Pelvic Fracture	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Pneumoconiosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Pneumothorax Traumatic	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Post Procedural Swelling	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Subdural Haematoma	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Investigations Biopsy	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Investigations Blood Creatinine Increased	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Investigations Body Temperature Increased	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Investigations Neutrophil Count Decreased	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Investigations Prostatic Specific Antigen Increased	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Investigations Weight Decreased	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Metabolism and nutrition disorders Decreased Appetite	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Metabolism and nutrition disorders Dehydration	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Metabolism and nutrition disorders Diabetes Mellitus	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Metabolism and nutrition disorders Tumour Lysis Syndrome	2.1% 6/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Arthritis	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Back Pain	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Chondrocalcinosis Pyrophosphate	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Femoroacetabular Impingement	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Groin Pain	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Muscle Haemorrhage	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Lymphocytic Leukaemia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous Cell Lung Cancer	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Squamous Cell Carcinoma	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	1.7% 5/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchioloalveolar Carcinoma	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Myelomonocytic Leukaemia	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal Adenocarcinoma	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal Papilloma of Breast	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma in Situ	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Maxillofacial Sinus Neoplasm	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Central Nervous System	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Renal Cell Carcinoma	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative Neoplasm	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Carcinoma	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer Stage I	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Oncocytoma	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Skin	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial Spreading Melanoma Stage Unspecified	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Carotid Sinus Syndrome	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Cerebral Disorder	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Cerebral Infarction	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Cerebral Ischaemia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Cerebrovascular Accident	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Cognitive Disorder	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Depressed Level of Consciousness	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Encephalopathy	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Facial Paresis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Haemorrhage Intracranial	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Haemorrhagic Stroke	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Headache	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Loss of Consciousness	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Meningism	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Peripheral Sensory Neuropathy	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Post Herpetic Neuralgia	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Radiculopathy	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Syncope	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Transient Global Amnesia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Vascular Encephalopathy	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Psychiatric disorders Acute Stress Disorder	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Psychiatric disorders Alcoholic Psychosis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Psychiatric disorders Completed Suicide	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Psychiatric disorders Confusional State	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Psychiatric disorders Delirium	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Psychiatric disorders Mental Status Changes	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Acute Kidney Injury	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Calculus Bladder	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Dysuria	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Haematuria	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Nephropathy	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Nephropathy Toxic	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Renal Failure	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Renal Impairment	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Ureteric Stenosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Ureterolithiasis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Urge Incontinence	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Urinary Incontinence	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Renal and urinary disorders Urinary Retention	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Reproductive system and breast disorders Fibrocystic Breast Disease	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Reproductive system and breast disorders Genital Rash	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Reproductive system and breast disorders Pelvic Floor Muscle Weakness	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Reproductive system and breast disorders Penile Dysplasia	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Reproductive system and breast disorders Uterine Haemorrhage	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Reproductive system and breast disorders Uterine Prolapse	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Lung Infiltration	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary Congestion	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Pulmonary Sarcoidosis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Oedema	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Acute Febrile Neutrophilic Dermatosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Drug Eruption	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Excessive Granulation Tissue	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Hypersensitivity Vasculitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Pemphigoid	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Pemphigus	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Rash	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Rash Erythematous	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Skin Necrosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Aortic Aneurysm Rupture	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Arterial Stenosis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Deep Vein Thrombosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Haematoma	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Hypertension	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Hypertensive Crisis	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Hypotension	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Jugular Vein Thrombosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Lymphoedema	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Peripheral Arterial Occlusive Disease	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Peripheral Artery Occlusion	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Peripheral Artery Thrombosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Peripheral Ischaemia	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Thrombophlebitis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Thrombosis	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Vasculitis	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.35% 1/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.

Other adverse events

Measure	Ibrutinib+BR n=287 participants at risk Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.	Placebo+BR n=287 participants at risk Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.	Crossover to Ibrutinib n=183 participants at risk Participants in the placebo+BR treatment group could cross over to receive next-line ibrutinib treatment (420 mg \[3 \* 140 mg capsules\] orally once daily on a 28-day cycle) at the discretion of the investigator at the time of disease progression or if International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for treatment were met.
Infections and infestations Bronchitis	17.8% 51/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	10.1% 29/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	10.4% 19/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Anaemia	25.4% 73/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	27.5% 79/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	18.0% 33/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Leukopenia	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	6.3% 18/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Neutropenia	59.2% 170/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	55.4% 159/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	21.9% 40/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Blood and lymphatic system disorders Thrombocytopenia	31.4% 90/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	24.0% 69/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	13.1% 24/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Cardiac disorders Atrial Fibrillation	8.0% 23/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.7% 5/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	10.4% 19/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Eye disorders Cataract	7.0% 20/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.4% 8/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Eye disorders Dry Eye	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.1% 9/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.3% 6/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Eye disorders Vision Blurred	6.6% 19/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	6.6% 19/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Abdominal Pain	13.6% 39/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.4% 24/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Abdominal Pain Upper	8.0% 23/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.6% 16/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	6.0% 11/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Constipation	21.3% 61/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	17.4% 50/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.2% 15/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Diarrhoea	40.1% 115/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	23.7% 68/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	25.7% 47/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Dyspepsia	8.4% 24/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	7.3% 21/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.4% 8/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Gastroesophageal Reflux Disease	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.2% 12/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.2% 4/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Nausea	37.6% 108/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	35.2% 101/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.7% 16/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Toothache	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.7% 5/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Gastrointestinal disorders Vomiting	14.6% 42/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	15.7% 45/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.2% 15/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Asthenia	9.1% 26/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.4% 24/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.7% 5/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Chills	11.5% 33/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	10.8% 31/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.7% 5/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Fatigue	24.0% 69/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	23.0% 66/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	17.5% 32/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Influenza Like Illness	3.1% 9/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.5% 10/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	6.6% 12/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Mucosal Inflammation	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.4% 7/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Non-Cardiac Chest Pain	5.9% 17/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.5% 13/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Oedema Peripheral	17.1% 49/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	11.8% 34/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	11.5% 21/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
General disorders Pyrexia	25.8% 74/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	20.9% 60/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	12.0% 22/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Cellulitis	5.6% 16/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.8% 8/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.5% 10/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Conjunctivitis	7.0% 20/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.5% 10/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Herpes Zoster	8.4% 24/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.9% 17/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.8% 7/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Influenza	7.7% 22/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.6% 16/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.8% 7/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Oral Herpes	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	6.3% 18/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.8% 7/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pharyngitis	6.3% 18/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.5% 13/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Pneumonia	13.9% 40/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.7% 25/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	11.5% 21/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Respiratory Tract Infection	6.6% 19/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.5% 10/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.2% 15/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Sinusitis	13.2% 38/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.4% 24/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	13.7% 25/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Upper Respiratory Tract Infection	24.0% 69/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	17.4% 50/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	19.7% 36/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Infections and infestations Urinary Tract Infection	9.8% 28/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	14.2% 26/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Contusion	10.5% 30/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.1% 9/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.2% 15/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Injury, poisoning and procedural complications Infusion Related Reaction	15.7% 45/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	22.3% 64/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.55% 1/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Investigations Alanine Aminotransferase Increased	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.2% 12/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Investigations Blood Creatinine Increased	5.9% 17/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.4% 7/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.3% 6/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Investigations Neutrophil Count Decreased	7.3% 21/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.6% 16/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Investigations Platelet Count Decreased	5.9% 17/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.1% 9/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.1% 2/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Investigations Weight Decreased	6.3% 18/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	6.3% 18/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.7% 5/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Metabolism and nutrition disorders Decreased Appetite	14.6% 42/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	14.6% 42/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.7% 16/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Metabolism and nutrition disorders Hyperuricaemia	12.5% 36/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	7.0% 20/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.8% 7/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Metabolism and nutrition disorders Hypokalaemia	8.4% 24/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.2% 12/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.4% 8/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Arthralgia	16.4% 47/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	10.1% 29/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	13.7% 25/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Back Pain	14.3% 41/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	7.7% 22/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	12.6% 23/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Muscle Spasms	15.3% 44/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.9% 14/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	9.3% 17/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Myalgia	9.8% 28/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.9% 9/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Musculoskeletal and connective tissue disorders Pain in Extremity	7.3% 21/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	6.6% 12/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Dysgeusia	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.2% 15/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.6% 3/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Nervous system disorders Headache	17.1% 49/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	16.4% 47/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	9.8% 18/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Psychiatric disorders Anxiety	7.7% 22/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.8% 11/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.9% 9/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Psychiatric disorders Depression	6.3% 18/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.8% 8/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.2% 4/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Psychiatric disorders Insomnia	9.4% 27/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	7.3% 21/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.5% 10/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Cough	25.8% 74/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	26.1% 75/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	14.8% 27/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 22/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	10.1% 29/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	6.0% 11/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 22/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.5% 10/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.2% 15/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	5.6% 16/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.1% 9/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	2.2% 4/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	10.5% 30/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	7.0% 20/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.4% 8/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Productive Cough	7.3% 21/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	6.3% 18/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.9% 9/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Respiratory, thoracic and mediastinal disorders Viral Upper Respiratory Tract Infection	10.5% 30/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	7.0% 20/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	7.1% 13/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Dry Skin	9.4% 27/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.9% 17/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.8% 7/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Ecchymosis	4.9% 14/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.70% 2/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.5% 10/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Onychoclasis	3.5% 10/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	0.00% 0/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	5.5% 10/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Pruritus	11.8% 34/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	11.5% 33/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.9% 9/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Rash	22.0% 63/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	12.2% 35/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	8.2% 15/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	5.9% 17/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.8% 11/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	3.8% 7/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Skin and subcutaneous tissue disorders Skin Lesion	10.5% 30/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.7% 5/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	6.0% 11/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Haematoma	9.1% 26/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	1.0% 3/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	7.7% 14/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.
Vascular disorders Hypertension	16.4% 47/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	4.9% 14/287 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.	14.8% 27/183 • From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years) Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.

Additional Information

Medical Director Clinical Research

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER