Trial Outcomes & Findings for Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer (NCT NCT00555620)

Last Updated: 2013-01-14

Results Overview

Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having \>3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery \>14 days.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

76 participants

Primary outcome timeframe

Baseline up to Day 21

Results posted on

2013-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Overall Study STARTED	6	7	15	23	3	22
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	6	7	15	23	3	22

Reasons for withdrawal

Reasons for withdrawal
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Overall Study Death	0	1	0	0	0	1
Overall Study Study terminated by sponsor	0	0	1	0	0	0
Overall Study Adverse Event	0	0	1	5	0	1
Overall Study Objective progression or relapse	6	5	12	17	3	16
Overall Study Participant refused treatment	0	1	1	0	0	1
Overall Study Other	0	0	0	1	0	3

Baseline Characteristics

Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=6 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=7 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=15 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 n=23 Participants SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=3 Participants SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=22 Participants SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	Total n=76 Participants Total of all reporting groups
Age Continuous	55.2 years STANDARD_DEVIATION 5.8 • n=5 Participants	50.0 years STANDARD_DEVIATION 12.4 • n=7 Participants	50.9 years STANDARD_DEVIATION 11.3 • n=5 Participants	54.3 years STANDARD_DEVIATION 10.1 • n=4 Participants	63.3 years STANDARD_DEVIATION 11.6 • n=21 Participants	50.1 years STANDARD_DEVIATION 11.5 • n=8 Participants	52.4 years STANDARD_DEVIATION 10.9 • n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=8 Participants	23 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	17 Participants n=4 Participants	2 Participants n=21 Participants	14 Participants n=8 Participants	53 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 21

Population: DLT subpopulation analysis set population: all participants who received at least 1 dose of study drug and did not permanently discontinue during the first cycle of treatment for reasons other than a DLT or miss more than 3 consecutive doses of sunitinib or capecitabine for reasons other than for drug related toxicities within the first cycle.

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=6 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=6 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=14 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 n=21 Participants SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=3 Participants SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=22 Participants SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)	1 participants	0 participants	3 participants	2 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Population: Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662) Cmax SU011248	40.1 nanograms per milliliter (ng/mL) Standard Deviation 10.8	69.7 nanograms per milliliter (ng/mL) Standard Deviation 17.6	46.5 nanograms per milliliter (ng/mL) Standard Deviation 10.8	—	—	—
Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662) Cmax SU012662	14.0 nanograms per milliliter (ng/mL) Standard Deviation 11.3	23.7 nanograms per milliliter (ng/mL) Standard Deviation 9.9	16.6 nanograms per milliliter (ng/mL) Standard Deviation 3.3	—	—	—
Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662) Cmax total drug (SU011248+SU012662)	53.9 nanograms per milliliter (ng/mL) Standard Deviation 22.1	93.0 nanograms per milliliter (ng/mL) Standard Deviation 24.9	62.4 nanograms per milliliter (ng/mL) Standard Deviation 13.4	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Cmax of CAP Cycle 1, Day 1	7000 ng/mL Standard Deviation 7354	2051 ng/mL Standard Deviation 1109	11681 ng/mL Standard Deviation 8034	—	—	—
Cmax of CAP Cycle 1, Day 14	20491 ng/mL Standard Deviation 27098	1989 ng/mL Standard Deviation 1686	16276 ng/mL Standard Deviation 15832	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR) Cycle 1, Day 1	4800 ng/mL Standard Deviation 863	3352 ng/mL Standard Deviation 1255	8017 ng/mL Standard Deviation 3692	—	—	—
Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR) Cycle 1, Day 14	5500 ng/mL Standard Deviation 5982	2267 ng/mL Standard Deviation 933	8036 ng/mL Standard Deviation 3540	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR) Cycle 1, Day 1	4010 ng/mL Standard Deviation 1909	2891 ng/mL Standard Deviation 1099	7166 ng/mL Standard Deviation 4073	—	—	—
Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR) Cycle 1, Day 14	6259 ng/mL Standard Deviation 7381	2074 ng/mL Standard Deviation 765	10082 ng/mL Standard Deviation 5421	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU) Cycle 1, Day 1	176 ng/mL Standard Deviation 127	165 ng/mL Standard Deviation 63	495 ng/mL Standard Deviation 326	—	—	—
Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU) Cycle 1, Day 14	552 ng/mL Standard Deviation 641	153 ng/mL Standard Deviation 78	866 ng/mL Standard Deviation 473	—	—	—

SECONDARY outcome

Timeframe: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662) Cmin SU011248	29.0 ng/mL Standard Deviation 5.2	49.2 ng/mL Standard Deviation 13.0	30.2 ng/mL Standard Deviation 9.2	—	—	—
Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662) Cmin SU012662	11.9 ng/mL Standard Deviation 9.3	18.7 ng/mL Standard Deviation 7.9	11.1 ng/mL Standard Deviation 2.6	—	—	—
Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662) Cmin total drug (SU011248+SU012662)	41.6 ng/mL Standard Deviation 15.6	68.5 ng/mL Standard Deviation 16.4	41.8 ng/mL Standard Deviation 11.3	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Cmin of CAP Cycle 1, Day 1	24.8 ng/mL Standard Deviation 35.1	0.0 ng/mL Standard Deviation 0.0	0.0 ng/mL Standard Deviation 0.0	—	—	—
Cmin of CAP Cycle 1, Day 14	32.0 ng/mL Standard Deviation 45.2	0.0 ng/mL Standard Deviation 0.0	0.0 ng/mL Standard Deviation 0.0	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Cmin of 5'DFCR Cycle 1, Day 1	11.1 ng/mL Standard Deviation 15.7	13.0 ng/mL Standard Deviation 20.7	55.60 ng/mL Standard Deviation 100.9	—	—	—
Cmin of 5'DFCR Cycle 1, Day 14	50.5 ng/mL Standard Deviation 71.4	0.00 ng/mL Standard Deviation 0.00	0.00 ng/mL Standard Deviation 0.00	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Cmin of 5'DFUR Cycle 1, Day 1	0.0 ng/mL Standard Deviation 0.0	2.4 ng/mL Standard Deviation 7.1	34.4 ng/mL Standard Deviation 69.0	—	—	—
Cmin of 5'DFUR Cycle 1, Day 14	33.5 ng/mL Standard Deviation 47.4	0.0 ng/mL Standard Deviation 0.0	0.0 ng/mL Standard Deviation 0.0	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Cmin of 5-FU Cycle 1, Day 1	0.0 ng/mL Standard Deviation 0.0	0.0 ng/mL Standard Deviation 0.0	0.8 ng/mL Standard Deviation 2.5	—	—	—
Cmin of 5-FU Cycle 1, Day 14	0.0 ng/mL Standard Deviation 0.0	0.0 ng/mL Standard Deviation 0.0	0.0 ng/mL Standard Deviation 0.0	—	—	—

SECONDARY outcome

Timeframe: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662) Tmax SU011248	4.0 hour (hr) Interval 4.0 to 4.0	8.0 hour (hr) Interval 2.0 to 10.0	8.0 hour (hr) Interval 4.0 to 10.0	—	—	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662) Tmax SU012662	9.0 hour (hr) Interval 8.0 to 10.0	8.0 hour (hr) Interval 4.0 to 24.0	6.0 hour (hr) Interval 0.0 to 10.0	—	—	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662) Tmax total drug (SU011248+SU012662)	4.0 hour (hr) Interval 4.0 to 4.0	8.0 hour (hr) Interval 2.0 to 10.0	6.0 hour (hr) Interval 4.0 to 10.0	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Tmax for CAP Cycle 1, Day 1	4.3 hr Interval 0.5 to 8.0	2.0 hr Interval 0.5 to 3.0	0.5 hr Interval 0.3 to 4.0	—	—	—
Tmax for CAP Cycle 1, Day 14	0.3 hr Interval 0.3 to 0.3	2.0 hr Interval 0.5 to 4.0	0.4 hr Interval 0.0 to 3.0	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Tmax for 5'DFCR Cycle 1, Day 1	4.3 hr Interval 0.5 to 8.0	2.0 hr Interval 0.5 to 4.0	0.6 hr Interval 0.5 to 4.0	—	—	—
Tmax for 5'DFCR Cycle 1, Day 14	0.4 hr Interval 0.3 to 0.5	3.0 hr Interval 0.9 to 4.0	0.5 hr Interval 0.0 to 3.0	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Tmax for 5'DFUR Cycle 1, Day 1	4.5 hr Interval 1.0 to 8.0	2.0 hr Interval 0.5 to 4.0	0.8 hr Interval 0.5 to 4.0	—	—	—
Tmax for 5'DFUR Cycle 1, Day 14	0.4 hr Interval 0.3 to 0.5	3.0 hr Interval 0.9 to 4.0	0.5 hr Interval 0.0 to 3.0	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Tmax for 5-FU Cycle 1, Day 1	4.5 hr Interval 1.0 to 8.0	2.0 hr Interval 0.5 to 4.0	0.6 hr Interval 0.3 to 4.0	—	—	—
Tmax for 5-FU Cycle 1, Day 14	0.4 hr Interval 0.3 to 0.5	3.0 hr Interval 0.5 to 4.0	0.5 hr Interval 0.0 to 3.0	—	—	—

SECONDARY outcome

Timeframe: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Population: Not analyzed; t1/2 could not be accurately estimated due to the long t1/2 of SU and its active metabolite and due to short PK collection period of only 24 hrs.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=1 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=1 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
t1/2 for CAP Cycle 1, Day 1	0.3 hr Standard Deviation NA only 1 participant evaluated	0.3 hr Standard Deviation NA only 1 participant evaluated	0.4 hr Standard Deviation 0.11	—	—	—
t1/2 for CAP Cycle 1, Day 14	0.4 hr Standard Deviation NA only 1 participant evaluated	0.5 hr Standard Deviation NA only 1 participant evaluated	0.4 hr Standard Deviation 0.12	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=1 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=6 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
t1/2 for 5'DFCR Cycle 1, Day 1	0.7 hr Standard Deviation NA only 1 participant evaluated	1.0 hr Standard Deviation 0.4	0.8 hr Standard Deviation 0.2	—	—	—
t1/2 for 5'DFCR Cycle 1, Day 14	0.7 hr Standard Deviation NA only 1 participant evaluated	1.1 hr Standard Deviation 0.7	0.8 hr Standard Deviation 0.1	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=1 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=5 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
t1/2 for 5'DFUR Cycle 1, Day 1	0.7 hr Standard Deviation NA only 1 participant evaluated	1.0 hr Standard Deviation 0.4	0.7 hr Standard Deviation 0.1	—	—	—
t1/2 for 5'DFUR Cycle 1, Day 14	0.6 hr Standard Deviation NA only 1 participant evaluated	1.0 hr Standard Deviation 0.5	0.7 hr Standard Deviation 0.1	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=1 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=2 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
t1/2 for 5-FU Cycle 1, Day 1	0.8 hr Standard Deviation NA only 1 participant evaluated	1.2 hr Standard Deviation 0.8	0.6 hr Standard Deviation 0.1	—	—	—
t1/2 for 5-FU Cycle 1, Day 14	0.6 hr Standard Deviation NA only 1 participant evaluated	1.1 hr Standard Deviation 0.4	0.6 hr Standard Deviation 0.1	—	—	—

SECONDARY outcome

Timeframe: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662) AUC (0-24) SU011248	844 nanogram hours per milliliter (ng*hr/mL) Standard Deviation 155 • Interval 875.0 to 829.0	1420 nanogram hours per milliliter (ng*hr/mL) Standard Deviation 379	902 nanogram hours per milliliter (ng*hr/mL) Standard Deviation 230	—	—	—
Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662) AUC (0-24) SU012662	321 nanogram hours per milliliter (ng*hr/mL) Standard Deviation 254	524 nanogram hours per milliliter (ng*hr/mL) Standard Deviation 219	327 nanogram hours per milliliter (ng*hr/mL) Standard Deviation 64	—	—	—
Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662) AUC (0-24) total drug (SU011248+SU012662)	1163 nanogram hours per milliliter (ng*hr/mL) Standard Deviation 407 • Interval 875.0 to 829.0	1944 nanogram hours per milliliter (ng*hr/mL) Standard Deviation 533	1230 nanogram hours per milliliter (ng*hr/mL) Standard Deviation 273	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=1 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=7 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU CAP (n = 1, 4, 10)	7480 ng*hr/mL Standard Deviation NA Only 1 participant evaluated	2828 ng*hr/mL Standard Deviation 215	8069 ng*hr/mL Standard Deviation 3877	—	—	—
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU 5'DFCR (n = 1, 7, 10)	9200 ng*hr/mL Standard Deviation NA Only 1 participant evaluated	8853 ng*hr/mL Standard Deviation 1648	11467 ng*hr/mL Standard Deviation 2476	—	—	—
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU 5'DFUR (n = 1, 6, 10)	7770 ng*hr/mL Standard Deviation NA Only 1 participant evaluated	5703 ng*hr/mL Standard Deviation 1295	9099 ng*hr/mL Standard Deviation 2288	—	—	—
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU 5-FU (n = 1, 5, 9)	386 ng*hr/mL Standard Deviation NA Only 1 participant evaluated	285 ng*hr/mL Standard Deviation 119	489 ng*hr/mL Standard Deviation 190	—	—	—

SECONDARY outcome

Timeframe: Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=1 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=7 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU CAP (n = 1, 4, 9)	25435 ng*hr/mL Standard Deviation NA only 1 participant evaluated	2663 ng*hr/mL Standard Deviation 452	8865 ng*hr/mL Standard Deviation 6533	—	—	—
Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU 5'DFCR (n = 1, 7, 10)	15522 ng*hr/mL Standard Deviation NA only 1 participant evaluated	7087 ng*hr/mL Standard Deviation 1222	10091 ng*hr/mL Standard Deviation 2847	—	—	—
Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU 5'DFUR (n = 1, 6, 10)	15522 ng*hr/mL Standard Deviation NA only 1 participant evaluated	4822 ng*hr/mL Standard Deviation 1222	10291 ng*hr/mL Standard Deviation 3675	—	—	—
Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU 5-FU (n = 1, 5, 10)	1299 ng*hr/mL Standard Deviation NA only 1 participant evaluated	353 ng*hr/mL Standard Deviation 141	842 ng*hr/mL Standard Deviation 403	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP Cycle 1, Day 1	7555 ng*hr/mL Standard Deviation 135	2899 ng*hr/mL Standard Deviation 1580	7373 ng*hr/mL Standard Deviation 4199	—	—	—
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP Cycle 1, Day 14	13532 ng*hr/mL Standard Deviation 16648	3157 ng*hr/mL Standard Deviation 1171	8213 ng*hr/mL Standard Deviation 6432	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
AUClast for 5'DFCR Cycle 1, Day 1	12815 ng*hr/mL Standard Deviation 5494	8028 ng*hr/mL Standard Deviation 1963	11229 ng*hr/mL Standard Deviation 2516	—	—	—
AUClast for 5'DFCR Cycle 1, Day 14	8614 ng*hr/mL Standard Deviation 8477	6464 ng*hr/mL Standard Deviation 1377	9776 ng*hr/mL Standard Deviation 2868	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
AUClast for 5'DFUR Cycle 1, Day 1	8855 ng*hr/mL Standard Deviation 1761	5658 ng*hr/mL Standard Deviation 1237	8951 ng*hr/mL Standard Deviation 2248	—	—	—
AUClast for 5'DFUR Cycle 1, Day 14	8500 ng*hr/mL Standard Deviation 9192	4829 ng*hr/mL Standard Deviation 1015	10017 ng*hr/mL Standard Deviation 3637	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=2 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=9 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
AUClast for 5-FU Cycle 1, Day 1	355 ng*hr/mL Standard Deviation 27	291 ng*hr/mL Standard Deviation 95	506 ng*hr/mL Standard Deviation 200	—	—	—
AUClast for 5-FU Cycle 1, Day 14	688 ng*hr/mL Standard Deviation 802	350 ng*hr/mL Standard Deviation 129	854 ng*hr/mL Standard Deviation 390	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 21 of every even-numbered cycle up to 15 months

Population: Efficacy analysis set population: all participants enrolled in the study who received at least 1 dose of study medication (SU011248).

Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=6 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=7 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=15 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 n=23 Participants SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=3 Participants SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=22 Participants SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Percentage of Participants With Objective Response	16.7 percentage of participants Interval 0.4 to 64.1	42.9 percentage of participants Interval 9.9 to 81.6	46.7 percentage of participants Interval 21.3 to 73.4	43.5 percentage of participants Interval 23.2 to 65.5	0 percentage of participants Interval 0.0 to 70.8	45.5 percentage of participants Interval 24.4 to 67.8

SECONDARY outcome

Timeframe: Baseline up to Month 15

Population: Efficacy analysis set population; No participants in the SU 37.5 mg, OXA 110 mg/m\^2, CAP 2000 mg/m\^2 reporting group analyzed; all had stable disease during specified time frame

DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=1 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=3 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=7 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 n=10 Participants SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=10 Participants SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Duration of Response (DR)	14.1 months Interval 14.1 to 14.1	6.3 months Interval 6.0 to 10.9	10.5 months Interval 4.4 to 28.1	5.9 months Interval 2.8 to 12.8	6.3 months Interval 2.5 to 25.5	—

SECONDARY outcome

Timeframe: Baseline up to Month 15

Population: Efficacy analysis subset of population of participants who had an event

PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=6 Participants Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=6 Participants SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=11 Participants SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 n=16 Participants SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=3 Participants SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=17 Participants SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Progression-Free Survival (PFS)	3.2 months Interval 2.7 to 9.3	6.6 months Interval 2.5 to 8.0	6.4 months Interval 4.3 to 13.9	8.0 months Interval 4.7 to 9.4	2.8 months Interval 2.3 to 11.7	5.5 months Interval 4.7 to 10.1

Adverse Events

SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2

Serious events: 8 serious events

Other events: 15 other events

Deaths: 0 deaths

SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2

Serious events: 8 serious events

Other events: 23 other events

Deaths: 0 deaths

SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2

Serious events: 5 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=6 participants at risk Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=7 participants at risk SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=15 participants at risk SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 n=23 participants at risk SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=3 participants at risk SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=22 participants at risk SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Duodenal perforation	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Gastric perforation	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Nausea	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Vomiting	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Fatigue	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Pyrexia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Sudden death	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Hepatobiliary disorders Cholecystitis	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Infection	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Pneumonia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Pyelonephritis	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Pyelonephritis acute	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Urinary tract infection	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Metabolism and nutrition disorders Decreased appetite	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Nervous system disorders Cerebral haemorrhage	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Psychiatric disorders Suicide attempt	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Reproductive system and breast disorders Menorrhagia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Vascular disorders Deep vein thrombosis	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Vascular disorders Haemorrhage	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Infectious peritonitis	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.

Other adverse events

Other adverse events
Measure	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2 n=6 participants at risk Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2 n=7 participants at risk SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2 n=15 participants at risk SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2 n=23 participants at risk SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=3 participants at risk SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 n=22 participants at risk SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Blood and lymphatic system disorders Anaemia	66.7% 4/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	57.1% 4/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	60.0% 9/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	34.8% 8/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Blood and lymphatic system disorders Leukopenia	50.0% 3/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	42.9% 3/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Blood and lymphatic system disorders Neutropenia	83.3% 5/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	85.7% 6/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	100.0% 15/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	78.3% 18/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	66.7% 2/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	81.8% 18/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Blood and lymphatic system disorders Thrombocytopenia	66.7% 4/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	85.7% 6/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	66.7% 10/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	69.6% 16/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	66.7% 2/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	36.4% 8/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Ear and labyrinth disorders Hearing impaired	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Ear and labyrinth disorders Tinnitus	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Eye disorders Eyelid oedema	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	17.4% 4/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Eye disorders Vision blurred	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	21.7% 5/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	18.2% 4/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Abdominal distension	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Abdominal pain	66.7% 4/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	57.1% 4/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	46.7% 7/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	26.1% 6/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	45.5% 10/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Abdominal pain upper	50.0% 3/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	28.6% 2/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	20.0% 3/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	39.1% 9/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	27.3% 6/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Cheilitis	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Constipation	66.7% 4/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	42.9% 3/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	46.7% 7/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	34.8% 8/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	22.7% 5/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Diarrhoea	33.3% 2/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	42.9% 3/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	40.0% 6/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	52.2% 12/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	50.0% 11/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Dry mouth	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Dyspepsia	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	40.0% 6/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	21.7% 5/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.6% 3/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.0% 3/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Gingival pain	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Haematochezia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Ileus	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Melaena	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Nausea	50.0% 3/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	85.7% 6/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	80.0% 12/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	73.9% 17/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	66.7% 2/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	77.3% 17/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Rectal tenesmus	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Stomatitis	83.3% 5/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	42.9% 3/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	53.3% 8/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	43.5% 10/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	31.8% 7/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Toothache	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Gastrointestinal disorders Vomiting	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	57.1% 4/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 5/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	34.8% 8/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	31.8% 7/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Asthenia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.0% 3/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Chest discomfort	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Chest pain	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Chills	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Face oedema	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	28.6% 2/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	30.4% 7/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Fatigue	100.0% 6/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	85.7% 6/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 5/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	39.1% 9/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	36.4% 8/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Mucosal inflammation	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Oedema	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Oedema peripheral	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Pain	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
General disorders Pyrexia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	17.4% 4/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Hepatobiliary disorders Cholangitis	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	21.7% 5/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	66.7% 2/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Hepatobiliary disorders Jaundice	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Immune system disorders Hypersensitivity	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Herpes zoster	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Infection	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Nasopharyngitis	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	20.0% 3/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Upper respiratory tract infection	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Urinary tract infection	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Investigations Alanine aminotransferase increased	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	17.4% 4/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.6% 3/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Investigations Aspartate aminotransferase increased	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	21.7% 5/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Investigations Blood bilirubin increased	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Investigations Blood creatinine increased	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Investigations Haemoglobin decreased	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Investigations International normalised ratio increased	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Investigations Liver function test abnormal	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Investigations Platelet count	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Investigations Weight decreased	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	20.0% 3/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Metabolism and nutrition disorders Decreased appetite	83.3% 5/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	85.7% 6/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	73.3% 11/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	65.2% 15/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	100.0% 3/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	59.1% 13/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Metabolism and nutrition disorders Hyponatraemia	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.0% 3/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Musculoskeletal and connective tissue disorders Back pain	33.3% 2/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.0% 3/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.6% 3/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Musculoskeletal and connective tissue disorders Flank pain	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Nervous system disorders Dizziness	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	27.3% 6/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Nervous system disorders Dysgeusia	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	30.4% 7/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Nervous system disorders Headache	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	20.0% 3/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	17.4% 4/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	22.7% 5/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Nervous system disorders Hyperaesthesia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Nervous system disorders Neuropathy peripheral	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	26.1% 6/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	36.4% 8/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Nervous system disorders Paraesthesia	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Nervous system disorders Peripheral sensory neuropathy	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	20.0% 3/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	26.1% 6/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	22.7% 5/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Nervous system disorders Tremor	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Psychiatric disorders Anxiety	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Psychiatric disorders Insomnia	33.3% 2/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	26.7% 4/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Renal and urinary disorders Dysuria	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Renal and urinary disorders Urinary retention	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.0% 3/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	18.2% 4/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.0% 3/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	28.6% 2/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Respiratory, thoracic and mediastinal disorders Hiccups	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Respiratory, thoracic and mediastinal disorders Nasal oedema	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	17.4% 4/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	9.1% 2/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Skin and subcutaneous tissue disorders Alopecia	33.3% 2/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	26.7% 4/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	34.8% 8/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	18.2% 4/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Skin and subcutaneous tissue disorders Rash	33.3% 2/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.6% 3/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	13.3% 2/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Skin and subcutaneous tissue disorders Urticaria	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Vascular disorders Flushing	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.3% 1/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Vascular disorders Haematoma	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Vascular disorders Hypertension	16.7% 1/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	6.7% 1/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	8.7% 2/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	4.5% 1/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Vascular disorders Hypotension	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	14.3% 1/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Infections and infestations Pericoronitis	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	28.6% 2/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/6 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/7 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/15 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/23 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	33.3% 1/3 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.	0.00% 0/22 The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER