Trial Outcomes & Findings for A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NCT NCT04487080)

NCT ID: NCT04487080

Last Updated: 2025-11-13

Results Overview

PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) the absence of progression, whichever came first. Disease progression was defined using RECIST 1.1 as a 20 percent (%) increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 millimeters (mL). Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 1074 participants
• Primary outcome timeframe: From randomization to either disease progression or death whichever occurs first (up to 32.8 months)
• Results posted on: 2025-11-13

Participant Flow

Currently, results posted till cut-off date 11-Aug-2023 (primary completion date). After analyzing primary analysis of progression free survival, participants were transitioned to an open-label extension (OLE) phase. Participants who continue to benefit from study treatment(s), as determined by investigator, may continue to receive access to study treatment(s) within study by transferring to long-term extension phase. OLE phase is still ongoing and results will be posted upon study completion.

Participant milestones

Measure	Experimental: Arm A (Open-label): Amivantamab + Lazertinib Participants received combination therapy of amivantamab 1050 milligrams (mg) for body weight (BW) less than (\<) 80 kilograms (kg) or 1400 mg for BW greater than or equal to (\>=) 80 kg intravenous (IV) infusion once weekly in 28-day treatment cycles: at Cycle 1 Days 1/2 (split dose, Day 1: 350 mg regardless of BW; Day 2: 700 mg or 1050 mg \[if BW \>=80 kg\]), 8, 15, and 22 and then once every 2 weeks (at Day 1 and 15) from Cycle 2 onwards; and lazertinib 240 mg (3 tablets of 80 mg) orally once daily. Participants continued treatment until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib Participants received osimertinib 80 mg capsule orally once daily along with 3 tablets of matching placebo of lazertinib 240 mg tablets orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib Participants received lazertinib 240 mg (3 tablets of 80 mg) orally once daily along with single capsule of matching placebo of osimertinib 80 mg orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
Overall Study STARTED	429	429	216
Overall Study Treated	421	428	213
Overall Study COMPLETED	94	113	54
Overall Study NOT COMPLETED	335	316	162

Reasons for withdrawal

Measure	Experimental: Arm A (Open-label): Amivantamab + Lazertinib Participants received combination therapy of amivantamab 1050 milligrams (mg) for body weight (BW) less than (\<) 80 kilograms (kg) or 1400 mg for BW greater than or equal to (\>=) 80 kg intravenous (IV) infusion once weekly in 28-day treatment cycles: at Cycle 1 Days 1/2 (split dose, Day 1: 350 mg regardless of BW; Day 2: 700 mg or 1050 mg \[if BW \>=80 kg\]), 8, 15, and 22 and then once every 2 weeks (at Day 1 and 15) from Cycle 2 onwards; and lazertinib 240 mg (3 tablets of 80 mg) orally once daily. Participants continued treatment until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib Participants received osimertinib 80 mg capsule orally once daily along with 3 tablets of matching placebo of lazertinib 240 mg tablets orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib Participants received lazertinib 240 mg (3 tablets of 80 mg) orally once daily along with single capsule of matching placebo of osimertinib 80 mg orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
Overall Study Withdrawal by Subject	19	18	13
Overall Study Lost to Follow-up	3	1	0
Overall Study Ongoing	313	297	149

Baseline Characteristics

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Experimental: Arm A (Open-label): Amivantamab + Lazertinib n=429 Participants Participants received combination therapy of amivantamab 1050 milligrams (mg) for body weight (BW) less than (\<) 80 kilograms (kg) or 1400 mg for BW greater than or equal to (\>=) 80 kg intravenous (IV) infusion once weekly in 28-day treatment cycles: at Cycle 1 Days 1/2 (split dose, Day 1: 350 mg regardless of BW; Day 2: 700 mg or 1050 mg \[if BW \>=80 kg\]), 8, 15, and 22 and then once every 2 weeks (at Day 1 and 15) from Cycle 2 onwards; and lazertinib 240 mg (3 tablets of 80 mg) orally once daily. Participants continued treatment until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib n=429 Participants Participants received osimertinib 80 mg capsule orally once daily along with 3 tablets of matching placebo of lazertinib 240 mg tablets orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib n=216 Participants Participants received lazertinib 240 mg (3 tablets of 80 mg) orally once daily along with single capsule of matching placebo of osimertinib 80 mg orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Total n=1074 Participants Total of all reporting groups
Age, Continuous	62.7 years STANDARD_DEVIATION 10.63 • n=10 Participants	61.9 years STANDARD_DEVIATION 11.52 • n=10 Participants	61.3 years STANDARD_DEVIATION 10.69 • n=20 Participants	62.1 years STANDARD_DEVIATION 11.01 • n=45 Participants
Sex: Female, Male Female	275 Participants n=10 Participants	251 Participants n=10 Participants	136 Participants n=20 Participants	662 Participants n=45 Participants
Sex: Female, Male Male	154 Participants n=10 Participants	178 Participants n=10 Participants	80 Participants n=20 Participants	412 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants n=10 Participants	45 Participants n=10 Participants	24 Participants n=20 Participants	125 Participants n=45 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	371 Participants n=10 Participants	382 Participants n=10 Participants	190 Participants n=20 Participants	943 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants	6 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=10 Participants	7 Participants n=10 Participants	4 Participants n=20 Participants	18 Participants n=45 Participants
Race (NIH/OMB) Asian	250 Participants n=10 Participants	251 Participants n=10 Participants	128 Participants n=20 Participants	629 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	2 Participants n=45 Participants
Race (NIH/OMB) Black or African American	4 Participants n=10 Participants	3 Participants n=10 Participants	4 Participants n=20 Participants	11 Participants n=45 Participants
Race (NIH/OMB) White	164 Participants n=10 Participants	165 Participants n=10 Participants	79 Participants n=20 Participants	408 Participants n=45 Participants
Race (NIH/OMB) More than one race	1 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	2 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants	4 Participants n=45 Participants
Region of Enrollment ARGENTINA	8 Participants n=10 Participants	11 Participants n=10 Participants	6 Participants n=20 Participants	25 Participants n=45 Participants
Region of Enrollment AUSTRALIA	5 Participants n=10 Participants	7 Participants n=10 Participants	1 Participants n=20 Participants	13 Participants n=45 Participants
Region of Enrollment BELGIUM	2 Participants n=10 Participants	4 Participants n=10 Participants	1 Participants n=20 Participants	7 Participants n=45 Participants
Region of Enrollment BRAZIL	38 Participants n=10 Participants	22 Participants n=10 Participants	9 Participants n=20 Participants	69 Participants n=45 Participants
Region of Enrollment CANADA	0 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants	2 Participants n=45 Participants
Region of Enrollment CHINA	81 Participants n=10 Participants	79 Participants n=10 Participants	43 Participants n=20 Participants	203 Participants n=45 Participants
Region of Enrollment FRANCE	12 Participants n=10 Participants	11 Participants n=10 Participants	6 Participants n=20 Participants	29 Participants n=45 Participants
Region of Enrollment GERMANY	2 Participants n=10 Participants	5 Participants n=10 Participants	2 Participants n=20 Participants	9 Participants n=45 Participants
Region of Enrollment HUNGARY	2 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	3 Participants n=45 Participants
Region of Enrollment INDIA	6 Participants n=10 Participants	16 Participants n=10 Participants	3 Participants n=20 Participants	25 Participants n=45 Participants
Region of Enrollment ISRAEL	3 Participants n=10 Participants	3 Participants n=10 Participants	2 Participants n=20 Participants	8 Participants n=45 Participants
Region of Enrollment ITALY	11 Participants n=10 Participants	8 Participants n=10 Participants	5 Participants n=20 Participants	24 Participants n=45 Participants
Region of Enrollment JAPAN	29 Participants n=10 Participants	32 Participants n=10 Participants	17 Participants n=20 Participants	78 Participants n=45 Participants
Region of Enrollment MALAYSIA	27 Participants n=10 Participants	23 Participants n=10 Participants	10 Participants n=20 Participants	60 Participants n=45 Participants
Region of Enrollment MEXICO	12 Participants n=10 Participants	14 Participants n=10 Participants	5 Participants n=20 Participants	31 Participants n=45 Participants
Region of Enrollment NETHERLANDS	1 Participants n=10 Participants	2 Participants n=10 Participants	0 Participants n=20 Participants	3 Participants n=45 Participants
Region of Enrollment POLAND	7 Participants n=10 Participants	6 Participants n=10 Participants	0 Participants n=20 Participants	13 Participants n=45 Participants
Region of Enrollment PORTUGAL	4 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants	8 Participants n=45 Participants
Region of Enrollment RUSSIAN FEDERATION	17 Participants n=10 Participants	15 Participants n=10 Participants	8 Participants n=20 Participants	40 Participants n=45 Participants
Region of Enrollment SOUTH KOREA	63 Participants n=10 Participants	68 Participants n=10 Participants	33 Participants n=20 Participants	164 Participants n=45 Participants
Region of Enrollment SPAIN	26 Participants n=10 Participants	33 Participants n=10 Participants	15 Participants n=20 Participants	74 Participants n=45 Participants
Region of Enrollment TAIWAN	24 Participants n=10 Participants	15 Participants n=10 Participants	13 Participants n=20 Participants	52 Participants n=45 Participants
Region of Enrollment THAILAND	15 Participants n=10 Participants	9 Participants n=10 Participants	5 Participants n=20 Participants	29 Participants n=45 Participants
Region of Enrollment TURKEY	15 Participants n=10 Participants	21 Participants n=10 Participants	4 Participants n=20 Participants	40 Participants n=45 Participants
Region of Enrollment UKRAINE	10 Participants n=10 Participants	11 Participants n=10 Participants	10 Participants n=20 Participants	31 Participants n=45 Participants
Region of Enrollment UNITED KINGDOM	2 Participants n=10 Participants	7 Participants n=10 Participants	2 Participants n=20 Participants	11 Participants n=45 Participants
Region of Enrollment UNITED STATES	7 Participants n=10 Participants	5 Participants n=10 Participants	11 Participants n=20 Participants	23 Participants n=45 Participants

PRIMARY outcome

Timeframe: From randomization to either disease progression or death whichever occurs first (up to 32.8 months)

Population: Full analysis set (FAS) included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received.

PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) the absence of progression, whichever came first. Disease progression was defined using RECIST 1.1 as a 20 percent (%) increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 millimeters (mL). Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment.

Outcome measures

Measure	Experimental: Arm A (Open-label): Amivantamab + Lazertinib n=429 Participants Participants received combination therapy of amivantamab 1050 milligrams (mg) for body weight (BW) less than (\<) 80 kilograms (kg) or 1400 mg for BW greater than or equal to (\>=) 80 kg intravenous (IV) infusion once weekly in 28-day treatment cycles: at Cycle 1 Days 1/2 (split dose, Day 1: 350 mg regardless of BW; Day 2: 700 mg or 1050 mg \[if BW \>=80 kg\]), 8, 15, and 22 and then once every 2 weeks (at Day 1 and 15) from Cycle 2 onwards; and lazertinib 240 mg (3 tablets of 80 mg) orally once daily. Participants continued treatment until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib n=429 Participants Participants received osimertinib 80 mg capsule orally once daily along with 3 tablets of matching placebo of lazertinib 240 mg tablets orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib n=216 Participants Participants received lazertinib 240 mg (3 tablets of 80 mg) orally once daily along with single capsule of matching placebo of osimertinib 80 mg orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)	23.72 Months Interval 19.12 to 27.66	16.59 Months Interval 14.78 to 18.46	18.46 Months Interval 14.75 to 20.11

SECONDARY outcome

Timeframe: Approximately 60 months (time from the date of randomization until the date of death due to any cause)

Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 32.8 months

ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 32.8 months

DOR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST v1.1 criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 60 months

The PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 60 months

TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 60 months

Intracranial PFS is defined as the time from randomization until the date of objective intracranial disease progression or death, whichever comes first, based on BICR using RECIST v1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 60 months

Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 30 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 60 months

Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 60 months

Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 60 months

Number of participants with physical examination abnormalities will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 60 months

Serum samples will be analyzed to determine concentrations of Amivantamab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 60 months

Plasma samples will be analyzed to determine concentrations of Lazertinib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 60 months

Number of participants with antibodies to amivantamab will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to approximately 60 months

The NSCLC-SAQ contains 7 items that assess cough, pain, dyspnea, fatigue, and poor appetite over a 7-day recall period. Each multi-item scale and individual item will be summarized using count and percent by visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to approximately 60 months

EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.

Outcome measures

Outcome data not reported

Adverse Events

Experimental: Arm A (Open-label): Amivantamab + Lazertinib

Serious events: 205 serious events

Other events: 419 other events

Deaths: 96 deaths

Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib

Serious events: 143 serious events

Other events: 409 other events

Deaths: 116 deaths

Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib

Serious events: 75 serious events

Other events: 210 other events

Deaths: 56 deaths

Serious adverse events

Measure	Experimental: Arm A (Open-label): Amivantamab + Lazertinib n=421 participants at risk Participants received combination therapy of amivantamab 1050 milligrams (mg) for body weight (BW) less than (\<) 80 kilograms (kg) or 1400 mg for BW greater than or equal to (\>=) 80 kg intravenous (IV) infusion once weekly in 28-day treatment cycles: at Cycle 1 Days 1/2 (split dose, Day 1: 350 mg regardless of BW; Day 2: 700 mg or 1050 mg \[if BW \>=80 kg\]), 8, 15, and 22 and then once every 2 weeks (at Day 1 and 15) from Cycle 2 onwards; and lazertinib 240 mg (3 tablets of 80 mg) orally once daily. Participants continued treatment until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib n=428 participants at risk Participants received osimertinib 80 mg capsule orally once daily along with 3 tablets of matching placebo of lazertinib 240 mg tablets orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib n=213 participants at risk Participants received lazertinib 240 mg (3 tablets of 80 mg) orally once daily along with single capsule of matching placebo of osimertinib 80 mg orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
Infections and infestations Sepsis	0.71% 3/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Septic Shock	0.71% 3/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Cystitis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Deep Vein Thrombosis	2.9% 12/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Venous Thrombosis	0.95% 4/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Venous Thrombosis Limb	0.95% 4/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.4% 3/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Jugular Vein Thrombosis	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Circulatory Collapse	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Embolism Venous	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Orthostatic Hypotension	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Sudden Death	0.95% 4/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Asthenia	0.71% 3/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Death	0.71% 3/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Fatigue	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Chest Pain	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Pain	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.95% 4/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Colitis	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Nausea	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Constipation	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Myocardial Infarction	0.95% 4/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Pericardial Effusion	0.95% 4/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.2% 5/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.9% 4/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Acute Coronary Syndrome	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Myocardial Rupture	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Dizziness	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Paraparesis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Blood Bilirubin Increased	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Blood Lactate Dehydrogenase Increased	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Gamma-Glutamyltransferase Increased	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Eye disorders Keratitis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Eye disorders Papilloedema	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Eye disorders Optic Atrophy	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Eye disorders Optic Ischaemic Neuropathy	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Cholecystitis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Psychiatric disorders Panic Disorder	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	6.2% 26/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.3% 10/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.8% 8/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.1% 9/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.0% 17/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.4% 3/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.7% 7/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.9% 8/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.4% 3/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.4% 6/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	1.2% 5/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.2% 5/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.4% 3/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.95% 4/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.6% 11/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.94% 2/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.71% 3/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hypersensitivity Pneumonitis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Haemorrhage	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Pneumonia	4.0% 17/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.9% 21/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.3% 7/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Covid-19	2.4% 10/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.3% 10/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.4% 3/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Cellulitis	0.95% 4/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.94% 2/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Urinary Tract Infection	0.71% 3/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Dermatitis Infected	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Achromobacter Infection	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Acinetobacter Sepsis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Appendicitis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Appendicitis Perforated	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Bacteraemia	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Covid-19 Pneumonia	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Device Related Infection	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Gastrointestinal Infection	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Pneumonia Aspiration	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Post Procedural Infection	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Pustule	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Respiratory Tract Infection	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.94% 2/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Skin Infection	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Staphylococcal Sepsis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Subcutaneous Abscess	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Tinea Cruris	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Urosepsis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Wound Infection	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Arthritis Bacterial	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Bronchitis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Dengue Fever	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Epididymitis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Gastroenteritis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Herpes Virus Infection	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Otitis Media Chronic	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Periodontitis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Scrub Typhus	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Soft Tissue Infection	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Tuberculosis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Infusion Related Reaction	2.1% 9/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.95% 4/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Hip Fracture	0.71% 3/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Accidental Overdose	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Ankle Fracture	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Fall	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Femur Fracture	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Lower Limb Fracture	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Muscle Rupture	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Radiation Injury	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Recall Phenomenon	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Tibia Fracture	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Upper Limb Fracture	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Head Injury	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Procedural Pneumothorax	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Radiation Pneumonitis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Subdural Haemorrhage	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Toxicity to Various Agents	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Peripheral Artery Thrombosis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Thrombosis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Embolism	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Haemorrhage	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Hypertension	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Hypotension	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Peripheral Arterial Occlusive Disease	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Superior Vena Cava Syndrome	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders General Physical Health Deterioration	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Oedema Peripheral	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Pyrexia	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Generalised Oedema	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Malaise	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Mucosal Inflammation	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Oedema	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Peripheral Swelling	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Gastric Ulcer Perforation	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Gastritis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Haemorrhoids	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Ileus	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Ileus Paralytic	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Intestinal Haemorrhage	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Intestinal Obstruction	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Large Intestine Perforation	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Mallory-Weiss Syndrome	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Pancreatitis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Pancreatitis Acute	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Peptic Ulcer	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Vomiting	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Intra-Abdominal Haemorrhage	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Mesenteric Vascular Occlusion	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	1.2% 5/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	1.2% 5/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.93% 4/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.71% 3/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Decreased Appetite	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypercalcaemia	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypophagia	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Cachexia	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Failure to Thrive	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Metabolic Acidosis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Arteriosclerosis Coronary Artery	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Atrial Fibrillation	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Atrioventricular Block Second Degree	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Cardiac Failure	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.2% 5/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Cardiac Tamponade	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Cardiopulmonary Failure	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Cardiovascular Insufficiency	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Coronary Artery Disease	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Cardiac Arrest	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.94% 2/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Myocardial Injury	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Cerebral Infarction	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.93% 4/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Cerebellar Ataxia	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Cerebral Haemorrhage	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Cerebral Thrombosis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Cerebrovascular Accident	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Haemorrhagic Stroke	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Headache	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Hydrocephalus	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Ischaemic Cerebral Infarction	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Loss of Consciousness	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Seizure	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Superior Sagittal Sinus Thrombosis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Brain Oedema	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Cognitive Disorder	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Dysarthria	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Dyskinesia	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Epilepsy	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Facial Paralysis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Hemiparesis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Intracranial Pressure Increased	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Meningism	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Spinal Cord Compression	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Syncope	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Tremor	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Alanine Aminotransferase Increased	1.9% 8/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.4% 6/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.9% 4/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Eastern Cooperative Oncology Group Performance Status Worsened	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Aspartate Aminotransferase Increased	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.93% 4/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.9% 4/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Troponin I Increased	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash	1.7% 7/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Drug Eruption	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Flank Pain	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.94% 2/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Spinal Pain	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Myeloid Leukaemia	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) High-Grade B-Cell Lymphoma	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Thyroid Cancer	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of Colon	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Haemorrhage	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteral Neoplasm	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Bone Marrow Failure	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Renal and urinary disorders Ureterolithiasis	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Renal and urinary disorders Renal Impairment	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Renal and urinary disorders Chronic Kidney Disease	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Renal and urinary disorders Renal Colic	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Renal and urinary disorders Renal Failure	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Renal and urinary disorders Urinary Retention	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Renal and urinary disorders Urogenital Disorder	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Eye disorders Giant Papillary Conjunctivitis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Hepatic Function Abnormal	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Cholelithiasis	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Product Issues Device Dislocation	0.48% 2/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Psychiatric disorders Delirium	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Psychiatric disorders Mental Status Changes	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Psychiatric disorders Confusional State	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Psychiatric disorders Major Depression	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 1/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Genital Tract Inflammation	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Reproductive system and breast disorders Pelvic Pain	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Surgical and medical procedures Pleurodesis	0.24% 1/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Surgical and medical procedures Cholecystectomy	0.00% 0/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.23% 1/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.

Other adverse events

Measure	Experimental: Arm A (Open-label): Amivantamab + Lazertinib n=421 participants at risk Participants received combination therapy of amivantamab 1050 milligrams (mg) for body weight (BW) less than (\<) 80 kilograms (kg) or 1400 mg for BW greater than or equal to (\>=) 80 kg intravenous (IV) infusion once weekly in 28-day treatment cycles: at Cycle 1 Days 1/2 (split dose, Day 1: 350 mg regardless of BW; Day 2: 700 mg or 1050 mg \[if BW \>=80 kg\]), 8, 15, and 22 and then once every 2 weeks (at Day 1 and 15) from Cycle 2 onwards; and lazertinib 240 mg (3 tablets of 80 mg) orally once daily. Participants continued treatment until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib n=428 participants at risk Participants received osimertinib 80 mg capsule orally once daily along with 3 tablets of matching placebo of lazertinib 240 mg tablets orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.	Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib n=213 participants at risk Participants received lazertinib 240 mg (3 tablets of 80 mg) orally once daily along with single capsule of matching placebo of osimertinib 80 mg orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
Eye disorders Dry Eye	8.8% 37/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.2% 18/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.3% 7/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Hepatobiliary disorders Hyperbilirubinaemia	6.7% 28/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.3% 14/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	8.0% 17/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Pyrexia	11.6% 49/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	8.4% 36/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	9.4% 20/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Mucosal Inflammation	10.5% 44/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.8% 12/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.8% 8/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Peripheral Swelling	5.2% 22/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.2% 5/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.94% 2/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Chest Pain	4.3% 18/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.7% 20/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.2% 11/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Non-Cardiac Chest Pain	3.1% 13/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.2% 18/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.2% 11/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Hypotension	6.9% 29/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.93% 4/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.94% 2/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Hypertension	5.0% 21/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.0% 17/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.6% 12/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	23.5% 99/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	17.1% 73/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	16.9% 36/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Dry Skin	15.9% 67/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	14.0% 60/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	17.8% 38/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Skin Fissures	9.5% 40/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.4% 23/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.3% 5/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	6.4% 27/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.9% 8/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.8% 8/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	5.7% 24/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.5% 15/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	6.1% 13/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Skin Ulcer	5.2% 22/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.47% 2/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.9% 4/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Psychiatric disorders Insomnia	9.7% 41/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	11.2% 48/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	6.1% 13/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	3.6% 15/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.7% 20/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	12.7% 27/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Paronychia	68.4% 288/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	28.3% 121/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	28.6% 61/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Covid-19	24.7% 104/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	22.7% 97/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	18.3% 39/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Conjunctivitis	10.9% 46/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.6% 7/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.3% 7/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Upper Respiratory Tract Infection	8.8% 37/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	10.3% 44/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	6.1% 13/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Urinary Tract Infection	7.1% 30/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.7% 20/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.7% 10/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Folliculitis	6.4% 27/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.6% 7/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.2% 9/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Infections and infestations Pneumonia	5.2% 22/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.1% 22/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.2% 11/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	29.2% 123/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	44.2% 189/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	31.9% 68/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Constipation	29.0% 122/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	12.9% 55/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	16.9% 36/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Stomatitis	29.0% 122/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	21.0% 90/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	17.8% 38/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Nausea	21.4% 90/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	13.6% 58/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	17.8% 38/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Vomiting	12.4% 52/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.4% 23/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	10.8% 23/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Haemorrhoids	9.7% 41/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.1% 9/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.8% 8/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Dyspepsia	7.6% 32/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.2% 18/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.2% 9/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal Pain Upper	6.2% 26/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.2% 18/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.2% 9/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	48.5% 204/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	6.1% 26/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	8.0% 17/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash	61.8% 260/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	30.6% 131/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	44.6% 95/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	29.0% 122/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	12.9% 55/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	21.1% 45/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Decreased Appetite	24.0% 101/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	17.8% 76/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	14.6% 31/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	20.7% 87/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	8.2% 35/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	7.0% 15/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	14.3% 60/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	7.0% 30/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.6% 12/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	9.0% 38/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	8.6% 37/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	10.3% 22/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	6.2% 26/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.7% 20/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.3% 5/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Oedema Peripheral	35.6% 150/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.6% 24/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	11.3% 24/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Asthenia	18.3% 77/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	10.7% 46/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	14.6% 31/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
General disorders Fatigue	16.2% 68/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	9.6% 41/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	10.3% 22/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Infusion Related Reaction	62.0% 261/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.00% 0/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Alanine Aminotransferase Increased	36.1% 152/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	12.9% 55/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	22.1% 47/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Aspartate Aminotransferase Increased	28.7% 121/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	13.6% 58/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	20.2% 43/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Gamma-Glutamyltransferase Increased	14.5% 61/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	7.2% 31/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	8.9% 19/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Blood Alkaline Phosphatase Increased	12.4% 52/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.1% 22/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	7.5% 16/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Blood Lactate Dehydrogenase Increased	11.6% 49/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.6% 24/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	9.9% 21/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Weight Decreased	8.8% 37/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	8.6% 37/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.3% 5/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Blood Creatinine Increased	7.4% 31/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	11.4% 49/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	12.7% 27/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Blood Creatine Phosphokinase Increased	3.3% 14/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.4% 19/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	7.5% 16/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Investigations Weight Increased	2.9% 12/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.1% 9/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.6% 12/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Paraesthesia	13.8% 58/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.8% 25/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	15.5% 33/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Headache	13.1% 55/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	12.6% 54/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	17.8% 38/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Dizziness	11.6% 49/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	7.2% 31/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	6.1% 13/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Neuropathy Peripheral	9.7% 41/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	0.70% 3/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	10.8% 23/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Hypoaesthesia	6.7% 28/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	1.6% 7/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	8.5% 18/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Peripheral Sensory Neuropathy	5.5% 23/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.3% 10/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	8.9% 19/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle Spasms	16.6% 70/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	7.5% 32/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	23.5% 50/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in Extremity	15.2% 64/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.1% 22/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	9.9% 21/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	12.4% 52/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.4% 19/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	5.2% 11/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back Pain	11.4% 48/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	10.5% 45/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	9.9% 21/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	9.0% 38/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	13.8% 59/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	11.7% 25/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	15.4% 65/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	20.6% 88/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	17.4% 37/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	15.0% 63/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.7% 16/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.7% 10/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.6% 49/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	14.5% 62/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	11.7% 25/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.8% 33/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.3% 14/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.3% 5/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Productive Cough	5.2% 22/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	4.4% 19/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	6.6% 14/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Anaemia	22.8% 96/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	21.3% 91/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	19.7% 42/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	15.7% 66/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	19.6% 84/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	9.4% 20/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Leukopenia	6.2% 26/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	15.4% 66/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	7.0% 15/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Lymphopenia	5.2% 22/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	7.2% 31/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	7.0% 15/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders Neutropenia	4.8% 20/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	13.1% 56/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	3.3% 7/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.
Vascular disorders Deep Vein Thrombosis	13.3% 56/421 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.3% 10/428 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.	2.8% 6/213 • From baseline (Day 1 of Cycle 1) up to 32.8 months The safety set included randomized participants who received at least 1 dose of study treatment.

Additional Information

Global Medical Head Onc

Janssen Research & Development

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 to allow for filing of a patent application.
• Publication restrictions are in place

Restriction type: OTHER