Trial Outcomes & Findings for Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Chemotherapy-Naïve Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT00560573)

NCT ID: NCT00560573

Last Updated: 2013-03-21

Results Overview

Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count \<500 cells/cubic millimeter \[mm\^3\]) \>=7 days, febrile neutropenia (Gr 3, fever \>=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet \<25,000 cells/mm\^3), Gr 3 thrombocytopenia \>=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 46 participants
• Primary outcome timeframe: Start of treatment up to end of Cycle 1, Day 21
• Results posted on: 2013-03-21

Participant Flow

Participant milestones

Measure	Figitumumab 6 mg/kg Figitumumab 6 milligram (mg)/kilogram (kg) was administered intravenously (IV) on Day 1 of each cycle over 2.5 hours (hr) up to 6 cycles. Gemcitabine 1250 mg/meter square (m\^2) was administered IV over approximately 30 minutes (min) on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation Figitumumab 20 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion The recommended phase 2 dose (R2PD) of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg, was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Overall Study STARTED	6	3	6	10	8	13
Overall Study Treated	6	3	6	10	7	13
Overall Study COMPLETED	0	0	0	0	1	0
Overall Study NOT COMPLETED	6	3	6	10	7	13

Reasons for withdrawal

Measure	Figitumumab 6 mg/kg Figitumumab 6 milligram (mg)/kilogram (kg) was administered intravenously (IV) on Day 1 of each cycle over 2.5 hours (hr) up to 6 cycles. Gemcitabine 1250 mg/meter square (m\^2) was administered IV over approximately 30 minutes (min) on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation Figitumumab 20 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion The recommended phase 2 dose (R2PD) of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg, was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Overall Study Death	4	1	4	5	1	10
Overall Study Lost to Follow-up	0	0	0	1	1	0
Overall Study Withdrawal by Subject	0	0	0	1	1	0
Overall Study Other	2	2	2	3	3	3
Overall Study Enrolled, not treated	0	0	0	0	1	0

Baseline Characteristics

Study Of CP-751,871 In Combination With Cisplatin And Gemcitabine In Chemotherapy-Naïve Patients With Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	All Participants n=45 Participants Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
Age Continuous	59.2 Years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Start of treatment up to end of Cycle 1, Day 21

Population: Safety analysis set: All enrolled participants in the dose escalation who received at least 1 dose of study medication.

Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count <500 cells/cubic millimeter [mm^3]) >=7 days, febrile neutropenia (Gr 3, fever >=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet <25,000 cells/mm^3), Gr 3 thrombocytopenia >=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment

Outcome measures

Measure	Figitumumab 6 mg/kg n=6 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=3 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation n=6 Participants Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Number of Participants With Dose-limiting Toxicities (DLT)	0 participants	0 participants	1 participants	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 for dose escalation and Cycle 4 for dose expansion

Population: PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Figitumumab pharmacokinetic (PK) data was analyzed using noncompartmental methods

Outcome measures

Measure	Figitumumab 6 mg/kg n=5 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=1 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation n=4 Participants Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion n=13 Participants The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Concentration at the End of Infusion (Cinf) for Figitumumab	120.4 mg/liter (L) Standard Deviation 26.690	137.0 mg/liter (L) Standard Deviation NA Data available from only 1 participant	435.0 mg/liter (L) Standard Deviation 129.01	513.4 mg/liter (L) Standard Deviation 136.58	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 1 for dose escation and 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 4 for expansion

Population: PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Figitumumab PK data was analyzed using noncompartmental methods

Outcome measures

Measure	Figitumumab 6 mg/kg n=5 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=1 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation n=4 Participants Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion n=12 Participants The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab	26020 mg*hr/L Standard Deviation 6780.6	21500 mg*hr/L Standard Deviation NA Data available from only 1 participant	84100 mg*hr/L Standard Deviation 18983	121200 mg*hr/L Standard Deviation 50493	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose) in Cycle 5 Day 1

Population: PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Concentration at the end of Cycle 4

Outcome measures

Measure	Figitumumab 6 mg/kg n=11 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab	113.6 mg/L Standard Deviation 47.266	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2

Population: PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence of (Cycle 2) figitumumab

Outcome measures

Measure	Figitumumab 6 mg/kg n=15 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=11 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation n=13 Participants Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion n=11 Participants The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Maximum Observed Plasma Concentration (Cmax) for Cisplatin	3.816 nanogram (ng)/mL Standard Deviation 1.5485	3.880 nanogram (ng)/mL Standard Deviation 0.8490	2.845 nanogram (ng)/mL Standard Deviation 0.8804	3.490 nanogram (ng)/mL Standard Deviation 1.1435	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2

Population: PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab

Outcome measures

Measure	Figitumumab 6 mg/kg n=15 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=11 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation n=13 Participants Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion n=11 Participants The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin	38.23 ng*hr/L Standard Deviation 7.2762	45.18 ng*hr/L Standard Deviation 15.005	37.12 ng*hr/L Standard Deviation 8.7975	48.29 ng*hr/L Standard Deviation 13.931	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8

Population: PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle) 1 and presence (Cycle 2) of figitumumab

Outcome measures

Measure	Figitumumab 6 mg/kg n=15 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=9 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Maximum Observed Plasma Concentration (Cmax) for Gemcitabine	12.85 ng/L Standard Deviation 6.9644	23.97 ng/L Standard Deviation 18.764	—	—	—	—

SECONDARY outcome

Timeframe: 0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8

Population: PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab

Outcome measures

Measure	Figitumumab 6 mg/kg n=15 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=9 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine	6.665 ng*hr/L Standard Deviation 3.0299	12.53 ng*hr/L Standard Deviation 7.5062	—	—	—	—

SECONDARY outcome

Timeframe: 0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2

Population: PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab

Outcome measures

Measure	Figitumumab 6 mg/kg n=13 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=11 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Maximum Observed Plasma Concentration (Cmax) for Pemetrexed	72.96 ng/mL Standard Deviation 25.581	93.13 ng/mL Standard Deviation 12.560	—	—	—	—

SECONDARY outcome

Timeframe: 0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2

Population: PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab

Outcome measures

Measure	Figitumumab 6 mg/kg n=13 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=11 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed	132.2 ng*hr/L Standard Deviation 71.512	161.6 ng*hr/L Standard Deviation 39.335	—	—	—	—

SECONDARY outcome

Timeframe: Screening, from Cycle 2 onwards computerized tomography (CT) scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)

Population: Efficacy analysis set: All participants with measurable disease at baseline, receiving at lesast 1 dose of figitumumab with a response assessment made by the investigator according to the RECIST system.

Percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 12 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants with non measurable disease were considered having a clinical benefit response only in the case of achievement of CR. Participants who developed early progressive disease post dosing and prior to response evaluation were considered to have progressed on study. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response

Outcome measures

Measure	Figitumumab 6 mg/kg n=45 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=23 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation n=13 Participants Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Percentage of Participants With Objective Response or Prolonged Stabilization	53.3 Percentage of participants Interval 37.9 to 68.3	56.5 Percentage of participants Interval 34.5 to 76.8	46.2 Percentage of participants Interval 19.2 to 74.9	—	—	—

SECONDARY outcome

Timeframe: Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)

Population: Efficacy analysis set: All participants with measurable disease at baseline, receiving at lesast 1 dose of figitumumab with a response assessment made by the investigator according to the RECIST system.

Time from the date of enrollment to date of documented disease progression, or death due to any cause

Outcome measures

Measure	Figitumumab 6 mg/kg n=40 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=21 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation n=10 Participants Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Progression-Free Survival (PFS)	5.7 months Interval 2.0 to 6.5	6.5 months Interval 1.7 to 10.2	5.4 months Interval 1.6 to 5.7	—	—	—

SECONDARY outcome

Timeframe: Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)

Population: No analysis of this parameter was performed. Due to the exploratory nature of the study, the analysis of the efficacy of figitumumab was limited to the assessment of clinical benefit response and PFS.

For responding patients (CR and PR): Time from the date that CR or PR was first recorded to the date of the first documentation of progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 min prior to figitumumab infusion in Cycle 1 and Cycle 4, end of study, fourth follow up visit (approximately 150 days after last dose)

Population: ADA analysis set: All enrolled participants who received at least 1 dose of study medication.

Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab

Outcome measures

Measure	Figitumumab 6 mg/kg n=6 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=3 Participants Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation n=6 Participants Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion n=10 Participants The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion n=7 Participants The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion n=13 Participants The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab C1D1 - Negative	50.0 Percentage of participants	33.3 Percentage of participants	50.0 Percentage of participants	80.0 Percentage of participants	100 Percentage of participants	100 Percentage of participants
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab C1D1 - Positive	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab C1D1 - Not determined	50.0 Percentage of participants	66.7 Percentage of participants	50.0 Percentage of participants	20.0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab C4D1 - Negative	16.7 Percentage of participants	0 Percentage of participants	50.0 Percentage of participants	30.0 Percentage of participants	71.4 Percentage of participants	53.8 Percentage of participants
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab C4D1 - Positive	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab C4D1 - Not determined	83.3 Percentage of participants	100 Percentage of participants	50.0 Percentage of participants	70.0 Percentage of participants	28.6 Percentage of participants	46.2 Percentage of participants
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab End of Study - Negative	83.3 Percentage of participants	0 Percentage of participants	50.0 Percentage of participants	20.0 Percentage of participants	42.9 Percentage of participants	46.2 Percentage of participants
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab End of Study - Positive	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab End of Study - Not determined	16.7 Percentage of participants	100 Percentage of participants	50.0 Percentage of participants	80.0 Percentage of participants	51.7 Percentage of participants	53.8 Percentage of participants
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab Follow Up - Negative	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	14.3 Percentage of participants	0 Percentage of participants
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab Follow Up - Positive	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab Follow Up - Not determined	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	85.7 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Day 8, end of study

Population: Biomarker analysis set: All enrolled participants who received at least 1 dose of study medication.

To monitor serum total IGF-1 levels as a potential pharmacodynamic response to figitumumab treatment

Outcome measures

Measure	Figitumumab 6 mg/kg n=40 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels Baseline	124.88 ng/mL Interval 91.0 to 143.0	—	—	—	—	—
Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels End of study	543.63 ng/mL Interval 343.0 to 694.0	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Cycle 1, up to Day 21

Population: Safety analysis set: All enrolled participants who received at least 1 dose of study medication.

The MTD was defined as the highest dose level below the maximum administered dose which caused 0 or 1 out of 6 participants to experience a DLT in that given cohort at Cycle 1

Outcome measures

Measure	Figitumumab 6 mg/kg n=45 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Maximum Tolerated Dose (MTD)	20 mg/kg	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to end of dose escalation, which was assessed in the last participant of the dose escalation portion of the study in Month 19

Population: Safety analysis set: All enrolled participants who received at least 1 dose of study medication.

The RP2D was determined after review and discussion by sponsor and investigators of the study data. Consideration was given to type and severity of toxicity as well as clinical suitability for long-term administration

Outcome measures

Measure	Figitumumab 6 mg/kg n=45 Participants Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Recommended Phase 2 Dose (RP2D)	20 mg/kg	—	—	—	—	—

Adverse Events

Figitumumab 6 mg/kg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Figitumumab 10 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Figitumumab 20 mg/kg Dose Escalation

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion

Serious events: 7 serious events

Other events: 10 other events

Deaths: 0 deaths

Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Figitumumab 20 mg/kg Pemetrexed Expansion

Serious events: 8 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Figitumumab 6 mg/kg n=6 participants at risk Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=3 participants at risk Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation n=6 participants at risk Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion n=10 participants at risk The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion n=7 participants at risk The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion n=13 participants at risk The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Infections and infestations Infection	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Lower respiratory tract infection	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Blindness unilateral	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Death	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders General physical health deterioration	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Sudden death	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Diverticulitis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Lung infection	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia necrotising	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Septic shock	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood glucose increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood urea increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Carbon dioxide increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count decreased	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cerebrovascular accident	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Diabetic hyperosmolar coma	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Myoclonus	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Confusional state	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure acute	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Arterial thrombosis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Arterial thrombosis limb	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Embolism	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Figitumumab 6 mg/kg n=6 participants at risk Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 10 mg/kg n=3 participants at risk Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Dose Escalation n=6 participants at risk Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion n=10 participants at risk The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion n=7 participants at risk The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m\^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m\^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.	Figitumumab 20 mg/kg Pemetrexed Expansion n=13 participants at risk The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m\^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m\^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
Blood and lymphatic system disorders Anaemia	66.7% 4/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	71.4% 5/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	38.5% 5/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	83.3% 5/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	83.3% 5/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	71.4% 5/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	61.5% 8/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	83.3% 5/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	42.9% 3/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	38.5% 5/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Arrhythmia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Ventricular dysfunction	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Deafness	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Hypoacusis	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Motion sickness	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Ototoxicity	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 2/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.1% 3/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Tinnitus	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctivitis	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.1% 3/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Keratoconjunctivitis sicca	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Vision blurred	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Visual impairment	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 2/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	42.9% 3/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Anal fissure	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Anal stenosis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	100.0% 6/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	66.7% 4/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 5/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	71.4% 5/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	61.5% 8/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	66.7% 4/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	57.1% 4/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.1% 3/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	46.2% 6/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diverticular perforation	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.1% 3/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dysphagia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Eructation	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Lip haemorrhage	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Mouth ulceration	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Odynophagia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oesophagitis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Periodontitis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Proctalgia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Rectal haemorrhage	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Tooth disorder	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Toothache	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	66.7% 4/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	57.1% 4/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	38.5% 5/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	66.7% 4/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	83.3% 5/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	60.0% 6/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	71.4% 5/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	46.2% 6/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.8% 4/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chills	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.8% 4/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	57.1% 4/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.8% 4/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Hypothermia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal dryness	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 5/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	42.9% 3/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.1% 3/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Performance status decreased	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	42.9% 3/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Hypersensitivity	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bacteriuria	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Candidiasis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 2/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypocalcaemia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cystitis	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infection	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral candidiasis	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral infection	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Paronychia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Respiratory tract infection	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Wound	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Activated partial thromboplastin time shortened	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.1% 3/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood albumin decreased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood alkaline phosphatase increased	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood bilirubin increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood calcium decreased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood chloride decreased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood chloride increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatine increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	42.9% 3/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	46.2% 6/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood glucose increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood immunoglobulin A decreased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood immunoglobulin G decreased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood magnesium decreased	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood magnesium increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood phosphorus decreased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood phosphorus increased	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood potassium increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood sodium decreased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood urea increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood uric acid increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Gamma-glutamyltransferase increased	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.1% 3/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Glucose urine present	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Glutamate dehydrogenase increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Glycosylated haemoglobin increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Haemoglobin decreased	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Lipase increased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Lymphocyte count decreased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Neutrophil count decreased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 2/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Prothrombin time prolonged	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count decreased	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	71.4% 5/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	46.2% 6/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	83.3% 5/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	66.7% 2/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	83.3% 5/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 5/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	57.1% 4/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	76.9% 10/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperproteinaemia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyponatraemia	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	42.9% 3/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthritis	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 2/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 2/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 2/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Amnesia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Aphonia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	57.1% 4/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysaesthesia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 2/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dyskinesia	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 2/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypokinesia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Neuropathy peripheral	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Neurotoxicity	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Spinal cord compression	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Status epilepticus	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Tremor	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Bradyphrenia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Confusional state	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Disorientation	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Hallucination	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Mood altered	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Glycosuria	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Oliguria	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Pollakiuria	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary incontinence	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary retention	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 2/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	38.5% 5/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.1% 3/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	66.7% 4/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 1/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	42.9% 3/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Hiccups	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	42.9% 3/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Productive cough	50.0% 3/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Madarosis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Onycholysis	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash follicular	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Deep vein thrombosis	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 1/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Pallor	16.7% 1/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Peripheral ischaemia	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/3 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/7 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 • Treatment-emergent adverse events (AE) were reported from the time of the first dose of study treatment up to 150 days after the last dose of study treatment. The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

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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