Trial Outcomes & Findings for Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Metastatic Colorectal Cancer (MK-0646-004) (NCT NCT00614393)

Last Updated: 2018-08-08

Results Overview

The OS of participants with metastatic colorectal cancer (CRC) expressing the KRAS wild-type (wtKRAS) tumor genotype (indicating no detection of KRAS mutation) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and is reported in months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

558 participants

Primary outcome timeframe

Up to 12 weeks after last dose of study drug (Up to 35 months)

Results posted on

2018-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	Dalotuzumab 10 mg/kg Q1W (DB) In double-blind (DB) Week 1, participants received cetuximab 400 mg/m\^2 intravenously (IV) loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV one time each week (Q1W) maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL) In the open-label (OL) portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV one time every two weeks (Q2W) for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) In DB Week 1, participants received a cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
Overall Study STARTED	180	8	10	180	180
Overall Study Treated	180	8	10	180	178
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	180	8	10	180	180

Reasons for withdrawal

Reasons for withdrawal
Measure	Dalotuzumab 10 mg/kg Q1W (DB) In double-blind (DB) Week 1, participants received cetuximab 400 mg/m\^2 intravenously (IV) loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV one time each week (Q1W) maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL) In the open-label (OL) portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV one time every two weeks (Q2W) for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) In DB Week 1, participants received a cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
Overall Study Adverse Event	20	2	3	13	21
Overall Study Lost to Follow-up	0	0	0	1	2
Overall Study Physician Decision	17	0	1	8	9
Overall Study Progressive Disease	118	5	5	138	130
Overall Study Protocol Violation	1	0	0	0	0
Overall Study Terminated by Sponsor	0	0	0	0	1
Overall Study Withdrawal by Subject	20	1	1	16	13
Overall Study Other	4	0	0	4	2
Overall Study Not Treated	0	0	0	0	2

Baseline Characteristics

Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Metastatic Colorectal Cancer (MK-0646-004)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dalotuzumab 10 mg/kg Q1W (DB) n=180 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL) n=8 Participants In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) n=10 Participants In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) n=180 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) n=178 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.	Total n=556 Participants Total of all reporting groups
Age, Continuous	59.6 Years STANDARD_DEVIATION 10.2 • n=5 Participants	55.6 Years STANDARD_DEVIATION 16.1 • n=7 Participants	64.4 Years STANDARD_DEVIATION 8.9 • n=5 Participants	59.4 Years STANDARD_DEVIATION 10.9 • n=4 Participants	58.4 Years STANDARD_DEVIATION 11.1 • n=21 Participants	59.2 Years STANDARD_DEVIATION 10.8 • n=10 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	70 Participants n=4 Participants	62 Participants n=21 Participants	192 Participants n=10 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	110 Participants n=4 Participants	116 Participants n=21 Participants	364 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks after last dose of study drug (Up to 35 months)

Population: The Intent-to-Treat (ITT) population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.

Outcome measures

Outcome measures
Measure	Dalotuzumab 10 mg/kg Q1W (DB) n=116 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL) In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) n=117 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) n=111 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
Overall Survival (OS)	10.8 Months Interval 7.9 to 12.9	—	—	11.6 Months Interval 9.6 to 14.3	14.0 Months Interval 10.7 to 16.1

PRIMARY outcome

Timeframe: Up to last dose of study drug (Up to 32 months)

Population: The ITT population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.

The PFS of participants with metastatic CRC expressing the wtKRAS genotype was defined as the time from the first day of study treatment to the first documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST 1.0) as documented by an independent core laboratory, or death due to any cause, whichever occurred first. Disease progression was defined as either a 20% or greater relative increase in the sum of diameters of target lesions OR an absolute increase of at least 5mm in the sum of lesions or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months.

Outcome measures

Outcome measures
Measure	Dalotuzumab 10 mg/kg Q1W (DB) n=116 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL) In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) n=117 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) n=111 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
Progression-free Survival (PFS)	3.9 Months Interval 2.7 to 5.4	—	—	5.4 Months Interval 3.9 to 6.7	5.6 Months Interval 4.1 to 6.7

PRIMARY outcome

Timeframe: Up to 30 days after last dose of study drug (Up to 33 months)

Population: The All Participants as Treated (APaT) population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.

An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. (Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4=Life-threatening consequences; urgent intervention indicated. Grade 5=Death related to AE.) Participants were monitored for AEs until the earlier of study discontinuation or 30 days after dalotuzumab/placebo discontinuation. AE grades were assessed using the National Cancer Institute (NCI) CTCAE, version 3.0.

Outcome measures

Outcome measures
Measure	Dalotuzumab 10 mg/kg Q1W (DB) n=180 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL) n=8 Participants In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) n=10 Participants In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) n=180 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) n=178 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
Percentage of Participants Who Have a Clinical or Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 to 5 Toxicity	82.8 Percentage of Participants	100.0 Percentage of Participants	90.0 Percentage of Participants	81.1 Percentage of Participants	75.8 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 30 days after last dose of study drug (Up to 33 months)

Population: The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.

An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. (Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4=Life-threatening consequences; urgent intervention indicated. Grade 5=Death related to AE.) Drug-related AEs were those AEs that were possibly, probably, or definitely related to study drug or protocol-specified procedures. Participants were monitored for AEs related to dalotuzumab or placebo until the earlier of study discontinuation or 30 days after dalotuzumab/placebo discontinuation. AE grades were assessed using the NCI CTCAE, version 3.0.

Outcome measures

Outcome measures
Measure	Dalotuzumab 10 mg/kg Q1W (DB) n=180 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL) n=8 Participants In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) n=10 Participants In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) n=180 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) n=178 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
Percentage of Participants Who Have a Drug-related Clinical or Laboratory CTCAE Grade 3 to 5 Toxicity	67.8 Percentage of Participants	100.0 Percentage of Participants	90.0 Percentage of Participants	72.8 Percentage of Participants	61.8 Percentage of Participants

PRIMARY outcome

Timeframe: Up to last dose of study drug (Up to 32 months)

Outcome measures

Outcome measures
Measure	Dalotuzumab 10 mg/kg Q1W (DB) n=180 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL) n=8 Participants In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) n=10 Participants In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) n=180 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) n=178 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
Percentage of Participants Who Discontinue Study Drug Due to an AE	11.1 Percentage of Participants	25.0 Percentage of Participants	30.0 Percentage of Participants	7.2 Percentage of Participants	11.8 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 30 days after last dose of study drug (Up to 33 months)

The percentage of participants who experienced an AE of infusion site reaction is presented.

Outcome measures

Outcome measures
Measure	Dalotuzumab 10 mg/kg Q1W (DB) n=180 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL) n=8 Participants In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) n=10 Participants In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) n=180 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) n=178 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
Percentage of Participants Who Experience an AE of Infusion Site Reaction	0.0 Percentage of Participants	12.5 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: Every 6 weeks (Up to 32 months)

ORR, using RECIST 1.0, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.

Outcome measures

Outcome measures
Measure	Dalotuzumab 10 mg/kg Q1W (DB) n=116 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL) In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB) n=117 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) n=111 Participants In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
Overall Response Rate (ORR) of Dalotuzumab in Combination With Cetuximab + Irinotecan Versus ORR of Cetuximab + Irinotecan Alone in Participants With Wild Type of Colorectal Cancer	21.6 Percentage of Participants	—	—	23.9 Percentage of Participants	26.1 Percentage of Participants

Adverse Events

Dalotuzumab 10 mg/kg Q1W (BD)

Serious events: 94 serious events

Other events: 178 other events

Deaths: 0 deaths

Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (OL)

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Dalotuzumab 10 mg/kg Q1W (OL)

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (DB)

Serious events: 77 serious events

Other events: 174 other events

Deaths: 0 deaths

Placebo + Cetuximab + Irinotecan (DB)

Serious events: 75 serious events

Other events: 172 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dalotuzumab 10 mg/kg Q1W (BD) n=180 participants at risk In DB Week 1, participants received cetuximab 400 mg/m\^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (OL) n=8 participants at risk In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) n=10 participants at risk In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (DB) n=180 participants at risk In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) n=178 participants at risk In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Blood and lymphatic system disorders Anaemia	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Blood and lymphatic system disorders Febrile neutropenia	3.3% 6/180 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.9% 7/180 • Number of events 8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/178 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Blood and lymphatic system disorders Neutropenia	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Cardiac disorders Acute coronary syndrome	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Cardiac disorders Angina pectoris	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Cardiac disorders Aortic valve stenosis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Cardiac disorders Atrial fibrillation	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Cardiac disorders Atrioventricular block complete	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Cardiac disorders Cardiac failure	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Cardiac disorders Myocardial infarction	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Ear and labyrinth disorders Deafness bilateral	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Eye disorders Blindness transient	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Eye disorders Retinal detachment	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Abdominal distension	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Abdominal pain	2.8% 5/180 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Abdominal pain lower	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Anal fistula	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Colitis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Colonic obstruction	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Constipation	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Diarrhoea	7.2% 13/180 • Number of events 13 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	5.6% 10/180 • Number of events 14 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.9% 7/178 • Number of events 8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Dysphagia	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Enteritis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Faecaloma	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Gastritis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Hiatus hernia	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Ileus	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	5.1% 9/178 • Number of events 10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Clostridial infection	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Intestinal obstruction	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Device related infection	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Intestinal perforation	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Large intestine perforation	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Nausea	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Oesophagitis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Pancreatitis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Peritonitis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Stomatitis	1.7% 3/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Subileus	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Vomiting	1.1% 2/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/178 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Asthenia	2.2% 4/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Death	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Disease progression	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Fatigue	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders General physical health deterioration	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Oedema	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Oedema peripheral	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Pyrexia	1.7% 3/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	4.5% 8/178 • Number of events 10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Systemic inflammatory response syndrome	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Hepatobiliary disorders Cholangitis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Hepatobiliary disorders Jaundice	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Abdominal abscess	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Sepsis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Abscess bacterial	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Bacterial sepsis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Biliary sepsis	0.56% 1/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Bronchopneumonia	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Catheter site infection	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Cellulitis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Ear infection	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Gastrointestinal infection	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Septic shock	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Infected skin ulcer	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Isosporiasis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Klebsiella sepsis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Lower respiratory tract infection	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Neutropenic sepsis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Oral candidiasis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Pneumonia	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.8% 5/180 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/178 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Pneumonia necrotising	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Pyelonephritis acute	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Rectal abscess	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Tooth infection	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Upper respiratory tract infection	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Urinary tract infection	1.7% 3/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Urinary tract infection bacterial	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Urosepsis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Injury, poisoning and procedural complications Ankle fracture	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Injury, poisoning and procedural complications Infusion related reaction	1.7% 3/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/178 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Dehydration	3.3% 6/180 • Number of events 7 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Hyperglycaemia	1.7% 3/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.3% 6/180 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Hypomagnesaemia	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Musculoskeletal and connective tissue disorders Bone pain	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	18.9% 34/180 • Number of events 34 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	15.0% 27/180 • Number of events 27 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	15.2% 27/178 • Number of events 27 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Altered state of consciousness	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Convulsion	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Diabetic hyperosmolar coma	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Headache	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Neuropathy peripheral	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Psychiatric disorders Confusional state	0.56% 1/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Renal and urinary disorders Anuria	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Renal and urinary disorders Azotaemia	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Renal and urinary disorders Calculus ureteric	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Renal and urinary disorders Haematuria	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Renal and urinary disorders Hydronephrosis	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Renal and urinary disorders Postrenal failure	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Renal and urinary disorders Renal failure	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Renal and urinary disorders Renal failure acute	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Diaphragmatic hernia	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.8% 5/180 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Dermatitis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Rash	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Vascular disorders Deep vein thrombosis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Vascular disorders Hypertension	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Vascular disorders Hypovolaemic shock	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Vascular disorders Thrombosis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.

Other adverse events

Other adverse events
Measure	Dalotuzumab 10 mg/kg Q1W (BD) n=180 participants at risk In DB Week 1, participants received cetuximab 400 mg/m\^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (OL) n=8 participants at risk In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Dalotuzumab 10 mg/kg Q1W (OL) n=10 participants at risk In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.	Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (DB) n=180 participants at risk In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.	Placebo + Cetuximab + Irinotecan (DB) n=178 participants at risk In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
Blood and lymphatic system disorders Anaemia	15.6% 28/180 • Number of events 70 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	15.0% 27/180 • Number of events 83 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	19.1% 34/178 • Number of events 82 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Blood and lymphatic system disorders Leukopenia	10.6% 19/180 • Number of events 46 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.8% 23/180 • Number of events 88 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	15.7% 28/178 • Number of events 69 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Blood and lymphatic system disorders Lymphopenia	2.8% 5/180 • Number of events 11 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/180 • Number of events 13 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	8.4% 15/178 • Number of events 20 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Blood and lymphatic system disorders Neutropenia	41.1% 74/180 • Number of events 249 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	30.0% 3/10 • Number of events 7 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	45.0% 81/180 • Number of events 375 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	42.1% 75/178 • Number of events 317 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Ear and labyrinth disorders Deafness	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Eye disorders Blepharitis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Eye disorders Conjunctivitis	4.4% 8/180 • Number of events 11 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	5.6% 10/180 • Number of events 18 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	8.4% 15/178 • Number of events 25 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Eye disorders Dark circles under eyes	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Eye disorders Dry eye	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/178 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Eye disorders Eye pruritus	2.2% 4/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Eye disorders Lacrimation increased	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.8% 5/178 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Eye disorders Vision blurred	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	25.0% 2/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/178 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Abdominal discomfort	2.8% 5/180 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.9% 7/180 • Number of events 9 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/178 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Abdominal pain	31.7% 57/180 • Number of events 94 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	37.5% 3/8 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	30.0% 3/10 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	31.7% 57/180 • Number of events 100 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	36.5% 65/178 • Number of events 141 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Abdominal pain upper	6.1% 11/180 • Number of events 19 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	6.7% 12/180 • Number of events 15 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	9.0% 16/178 • Number of events 24 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Anal fissure	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Constipation	26.7% 48/180 • Number of events 90 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	25.0% 2/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	22.2% 40/180 • Number of events 68 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	27.0% 48/178 • Number of events 79 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Nasopharyngitis	3.3% 6/180 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	5.0% 9/180 • Number of events 10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.4% 6/178 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Diarrhoea	76.7% 138/180 • Number of events 567 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	50.0% 4/8 • Number of events 18 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	90.0% 9/10 • Number of events 37 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	65.6% 118/180 • Number of events 445 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	68.0% 121/178 • Number of events 507 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Dry mouth	1.7% 3/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	6.1% 11/180 • Number of events 13 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.9% 7/178 • Number of events 7 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Dyspepsia	10.0% 18/180 • Number of events 21 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	7.2% 13/180 • Number of events 16 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	13.5% 24/178 • Number of events 38 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Dysphagia	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/180 • Number of events 7 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Erosive duodenitis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Gastritis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Nausea	50.0% 90/180 • Number of events 196 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	50.0% 4/8 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	50.0% 5/10 • Number of events 7 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	56.1% 101/180 • Number of events 236 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	53.9% 96/178 • Number of events 292 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Oral pain	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Proctalgia	5.6% 10/180 • Number of events 11 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.9% 7/180 • Number of events 8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/178 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Rectal haemorrhage	1.7% 3/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.9% 7/178 • Number of events 7 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Rectal tenesmus	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Reflux oesophagitis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Stomatitis	52.8% 95/180 • Number of events 223 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	60.0% 6/10 • Number of events 9 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	57.8% 104/180 • Number of events 255 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	37.6% 67/178 • Number of events 162 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Gastrointestinal disorders Vomiting	34.4% 62/180 • Number of events 99 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	25.0% 2/8 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	31.7% 57/180 • Number of events 120 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	28.7% 51/178 • Number of events 124 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Asthenia	26.7% 48/180 • Number of events 145 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	50.0% 4/8 • Number of events 12 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	30.0% 3/10 • Number of events 12 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	30.6% 55/180 • Number of events 156 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	21.3% 38/178 • Number of events 93 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Fatigue	41.1% 74/180 • Number of events 154 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	37.5% 3/8 • Number of events 8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	35.0% 63/180 • Number of events 119 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	33.7% 60/178 • Number of events 161 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Infusion site reaction	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Malaise	2.8% 5/180 • Number of events 7 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/180 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.4% 6/178 • Number of events 8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Mucosal inflammation	6.7% 12/180 • Number of events 22 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	7.8% 14/180 • Number of events 29 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	4.5% 8/178 • Number of events 18 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Oedema peripheral	6.1% 11/180 • Number of events 14 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	5.6% 10/180 • Number of events 15 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	9.0% 16/178 • Number of events 21 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
General disorders Pyrexia	10.0% 18/180 • Number of events 22 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	7.2% 13/180 • Number of events 15 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	16.3% 29/178 • Number of events 34 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Hepatobiliary disorders Hyperbilirubinaemia	5.0% 9/180 • Number of events 20 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.9% 7/180 • Number of events 9 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.9% 7/178 • Number of events 12 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Bronchitis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Candidiasis	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Fungal skin infection	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Lower respiratory tract infection	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Oesophageal candidiasis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Paronychia	28.3% 51/180 • Number of events 151 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	25.0% 2/8 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	30.0% 3/10 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	34.4% 62/180 • Number of events 183 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	20.8% 37/178 • Number of events 91 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Peritonitis bacterial	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Syphilis	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Urinary tract infection	7.2% 13/180 • Number of events 20 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	5.6% 10/180 • Number of events 12 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.4% 6/178 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Infections and infestations Vulvovaginal candidiasis	0.56% 1/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Injury, poisoning and procedural complications Accidental overdose	1.1% 2/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/180 • Number of events 11 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Injury, poisoning and procedural complications Tongue injury	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Investigations Alanine aminotransferase increased	17.8% 32/180 • Number of events 80 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	13.3% 24/180 • Number of events 70 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	9.0% 16/178 • Number of events 50 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Investigations Aspartate aminotransferase increased	9.4% 17/180 • Number of events 42 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 18/180 • Number of events 59 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	8.4% 15/178 • Number of events 33 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Investigations Blood alkaline phosphatase increased	3.9% 7/180 • Number of events 11 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.9% 7/180 • Number of events 8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	6.2% 11/178 • Number of events 14 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Investigations Blood glucose increased	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Investigations Weight decreased	20.6% 37/180 • Number of events 40 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	20.6% 37/180 • Number of events 41 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	11.2% 20/178 • Number of events 25 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Cachexia	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Decreased appetite	58.9% 106/180 • Number of events 208 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	30.0% 3/10 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	50.0% 90/180 • Number of events 191 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	41.6% 74/178 • Number of events 164 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Dehydration	3.3% 6/180 • Number of events 11 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/178 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Diabetes mellitus	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Hyperglycaemia	34.4% 62/180 • Number of events 220 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	30.0% 3/10 • Number of events 9 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	35.6% 64/180 • Number of events 292 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	18.5% 33/178 • Number of events 77 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Hyperuricaemia	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Hypocalcaemia	7.2% 13/180 • Number of events 27 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	6.1% 11/180 • Number of events 20 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	4.5% 8/178 • Number of events 19 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Hypokalaemia	8.3% 15/180 • Number of events 21 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	4.4% 8/180 • Number of events 10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	8.4% 15/178 • Number of events 19 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Hypomagnesaemia	20.6% 37/180 • Number of events 163 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	25.0% 2/8 • Number of events 23 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	20.0% 2/10 • Number of events 22 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	23.9% 43/180 • Number of events 131 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	20.8% 37/178 • Number of events 124 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Metabolism and nutrition disorders Malnutrition	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Musculoskeletal and connective tissue disorders Back pain	10.6% 19/180 • Number of events 30 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	11.7% 21/180 • Number of events 26 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	8.4% 15/178 • Number of events 34 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Musculoskeletal and connective tissue disorders Flank pain	1.7% 3/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	5.6% 10/180 • Number of events 11 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/178 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Musculoskeletal and connective tissue disorders Muscle spasms	3.9% 7/180 • Number of events 9 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	25.0% 2/8 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	5.0% 9/180 • Number of events 15 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.9% 7/178 • Number of events 11 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.2% 4/180 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	6.1% 11/180 • Number of events 16 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	4.5% 8/178 • Number of events 10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Musculoskeletal and connective tissue disorders Pain in extremity	6.1% 11/180 • Number of events 12 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	4.4% 8/180 • Number of events 10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	7.3% 13/178 • Number of events 18 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Disturbance in attention	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Dizziness	8.9% 16/180 • Number of events 24 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	11.7% 21/180 • Number of events 31 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	11.8% 21/178 • Number of events 25 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Dysgeusia	3.9% 7/180 • Number of events 7 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	4.4% 8/180 • Number of events 14 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.4% 6/178 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Headache	7.8% 14/180 • Number of events 14 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	6.7% 12/180 • Number of events 14 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	8.4% 15/178 • Number of events 39 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Lethargy	9.4% 17/180 • Number of events 75 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	20.0% 2/10 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	7.2% 13/180 • Number of events 33 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.7% 19/178 • Number of events 90 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Neuropathy peripheral	3.3% 6/180 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	5.6% 10/178 • Number of events 13 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Peripheral sensory neuropathy	6.1% 11/180 • Number of events 25 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	8.3% 15/180 • Number of events 36 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.8% 5/178 • Number of events 11 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Presyncope	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Nervous system disorders Tremor	1.7% 3/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/180 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.56% 1/178 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Psychiatric disorders Depression	1.7% 3/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/178 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Psychiatric disorders Insomnia	12.8% 23/180 • Number of events 25 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	8.9% 16/180 • Number of events 18 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.9% 23/178 • Number of events 35 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Renal and urinary disorders Renal impairment	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Renal and urinary disorders Urinary hesitation	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Cough	13.3% 24/180 • Number of events 31 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	16.1% 29/180 • Number of events 47 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	14.0% 25/178 • Number of events 29 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.7% 21/180 • Number of events 28 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.2% 22/180 • Number of events 28 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	14.0% 25/178 • Number of events 34 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.9% 16/180 • Number of events 20 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	25.0% 2/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	30.0% 3/10 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	7.8% 14/180 • Number of events 22 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.1% 18/178 • Number of events 21 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/180 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/178 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.3% 6/180 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.8% 5/180 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/178 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Respiratory, thoracic and mediastinal disorders Productive cough	3.9% 7/180 • Number of events 7 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	5.0% 9/180 • Number of events 9 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.9% 7/178 • Number of events 8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Acne	6.1% 11/180 • Number of events 35 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.8% 23/180 • Number of events 48 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	8.4% 15/178 • Number of events 33 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Alopecia	25.6% 46/180 • Number of events 80 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	25.0% 2/8 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	27.8% 50/180 • Number of events 68 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	28.1% 50/178 • Number of events 70 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Dermatitis acneiform	48.9% 88/180 • Number of events 195 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	100.0% 8/8 • Number of events 18 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	90.0% 9/10 • Number of events 31 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	47.8% 86/180 • Number of events 186 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	45.5% 81/178 • Number of events 231 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Dry skin	32.8% 59/180 • Number of events 95 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	25.0% 2/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	40.0% 4/10 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	35.6% 64/180 • Number of events 96 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	32.0% 57/178 • Number of events 85 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Nail disorder	4.4% 8/180 • Number of events 24 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	8.3% 15/180 • Number of events 35 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.4% 6/178 • Number of events 13 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	8.9% 16/180 • Number of events 29 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	20.0% 2/10 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	8.3% 15/180 • Number of events 29 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	6.7% 12/178 • Number of events 25 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Pruritus	23.9% 43/180 • Number of events 69 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	30.0% 3/10 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	29.4% 53/180 • Number of events 93 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	24.2% 43/178 • Number of events 77 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Rash	42.2% 76/180 • Number of events 217 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	36.7% 66/180 • Number of events 184 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	33.7% 60/178 • Number of events 165 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Rash papular	0.56% 1/180 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/180 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	3.4% 6/178 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Skin fissures	26.1% 47/180 • Number of events 86 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	25.0% 2/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	30.6% 55/180 • Number of events 108 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	27.0% 48/178 • Number of events 105 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	3.9% 7/180 • Number of events 13 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/8 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	5.6% 10/180 • Number of events 24 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/178 • Number of events 10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Vascular disorders Flushing	0.56% 1/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.7% 3/178 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Vascular disorders Hypertension	1.7% 3/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	25.0% 2/8 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/180 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	4.5% 8/178 • Number of events 14 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.
Vascular disorders Hypotension	1.7% 3/180 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	12.5% 1/8 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	0.00% 0/10 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	2.2% 4/180 • Number of events 6 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.	1.1% 2/178 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 33 months) The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER