Trial Outcomes & Findings for DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain (NCT NCT02318706)

Last Updated: 2020-11-02

Results Overview

Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

854 participants

Primary outcome timeframe

Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg])

Results posted on

2020-11-02

Participant Flow

A total of 854 participants who met all inclusion and no exclusion criteria were enrolled; 834 were randomized to treatment in the double-blind phase. Twenty participants were excluded by the sponsor due to a serious Good Clinical Practice violation (inform consent form-related). A total of 214 participants enrolled in the open-label extension.

Participants were randomized to DS-5565 (15, 20, or 30 mg) or placebo in the double-blind (DB) phase and open-label DS-5565 in the long-term (LT) phase. Patients who complete the DB phase may not enroll in the LT phase. DB phase determine significant difference vs placebo (\~750 target cases). LT phase confirm long-term safety (\~180 target cases).

Participant milestones

Participant milestones
Measure	Placebo Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.	DS-5565 15mg QD Participants who received an oral dose of DS-5565 15 mg every day (QD). During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week. During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks.	DS-5565 20 mg (10 mg BID) Participants who received an oral dose of DS-5565 20 mg (10 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week. During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks.	DS-5565 30 mg (15 mg BID) Participants who received an oral dose of DS-5565 30 mg (15 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week. During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks.	DS-5565 Open-label Extension Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.
Double-blind Phase STARTED	334	166	168	166	0
Double-blind Phase COMPLETED	309	154	150	142	0
Double-blind Phase NOT COMPLETED	25	12	18	24	0
Open-label Extension Phase STARTED	0	0	0	0	214
Open-label Extension Phase COMPLETED	0	0	0	0	172
Open-label Extension Phase NOT COMPLETED	0	0	0	0	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.	DS-5565 15mg QD Participants who received an oral dose of DS-5565 15 mg every day (QD). During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week. During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks.	DS-5565 20 mg (10 mg BID) Participants who received an oral dose of DS-5565 20 mg (10 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week. During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks.	DS-5565 30 mg (15 mg BID) Participants who received an oral dose of DS-5565 30 mg (15 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week. During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks.	DS-5565 Open-label Extension Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.
Double-blind Phase Adverse Event	7	4	3	10	0
Double-blind Phase Lost to Follow-up	1	0	0	0	0
Double-blind Phase Protocol Violation	4	2	4	3	0
Double-blind Phase Withdrawal by Subject	9	5	7	10	0
Double-blind Phase Other	4	1	2	1	0
Double-blind Phase Death	0	0	2	0	0
Open-label Extension Phase Adverse Event	0	0	0	0	21
Open-label Extension Phase Lack of Efficacy	0	0	0	0	1
Open-label Extension Phase Death	0	0	0	0	1
Open-label Extension Phase Withdrawal by Subject	0	0	0	0	19

Baseline Characteristics

DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=334 Participants Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.	DS-5565 15mg QD n=166 Participants Participants who received an oral dose of DS-5565 15 mg QD. During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week. During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks.	DS-5565 20 mg (10 mg BID) n=168 Participants Participants who received an oral dose of DS-5565 20 mg (10 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week. During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks.	DS-5565 30 mg (15 mg BID) n=166 Participants Participants who received an oral dose of DS-5565 30 mg (15 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week. During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks.	Total n=834 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	198 Participants n=5 Participants	99 Participants n=7 Participants	102 Participants n=5 Participants	98 Participants n=4 Participants	497 Participants n=21 Participants
Age, Categorical >=65 years	136 Participants n=5 Participants	67 Participants n=7 Participants	66 Participants n=5 Participants	68 Participants n=4 Participants	337 Participants n=21 Participants
Age, Continuous	61.0 years STANDARD_DEVIATION 10.5 • n=5 Participants	61.9 years STANDARD_DEVIATION 8.4 • n=7 Participants	61.2 years STANDARD_DEVIATION 10.1 • n=5 Participants	61.8 years STANDARD_DEVIATION 9.4 • n=4 Participants	61.4 years STANDARD_DEVIATION 9.8 • n=21 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	53 Participants n=7 Participants	47 Participants n=5 Participants	36 Participants n=4 Participants	229 Participants n=21 Participants
Sex: Female, Male Male	241 Participants n=5 Participants	113 Participants n=7 Participants	121 Participants n=5 Participants	130 Participants n=4 Participants	605 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	334 Participants n=5 Participants	166 Participants n=7 Participants	168 Participants n=5 Participants	166 Participants n=4 Participants	834 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	334 Participants n=5 Participants	166 Participants n=7 Participants	168 Participants n=5 Participants	166 Participants n=4 Participants	834 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg])

Population: ADPS was assessed in the Modified-Intent-to-Treat Analysis Set.

Outcome measures

Outcome measures
Measure	Placebo n=330 Participants Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.	DS-5565 15mg QD n=164 Participants Participants who received an oral dose of DS-5565 15 mg every day (QD). During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week. During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks.	DS-5565 20 mg (10 mg BID) n=165 Participants Participants who received an oral dose of DS-5565 20 mg (10 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week. During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks.	DS-5565 30 mg (15 mg BID) n=165 Participants Participants who received an oral dose of DS-5565 30 mg (15 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week. During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks.
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 2	-0.46 units on a scale Standard Deviation 0.96	-0.60 units on a scale Standard Deviation 0.90	-0.72 units on a scale Standard Deviation 1.12	-1.00 units on a scale Standard Deviation 1.27
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 1	-0.26 units on a scale Standard Deviation 0.79	-0.39 units on a scale Standard Deviation 0.67	-0.40 units on a scale Standard Deviation 0.85	-0.60 units on a scale Standard Deviation 1.01
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 3	-0.57 units on a scale Standard Deviation 1.08	-0.78 units on a scale Standard Deviation 1.02	-0.84 units on a scale Standard Deviation 1.22	-1.33 units on a scale Standard Deviation 1.49
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 4	-0.70 units on a scale Standard Deviation 1.12	-0.87 units on a scale Standard Deviation 1.13	-0.94 units on a scale Standard Deviation 1.38	-1.43 units on a scale Standard Deviation 1.63
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 5	-0.84 units on a scale Standard Deviation 1.17	-0.97 units on a scale Standard Deviation 1.20	-1.06 units on a scale Standard Deviation 1.50	-1.48 units on a scale Standard Deviation 1.68
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 9	-1.16 units on a scale Standard Deviation 1.42	-1.13 units on a scale Standard Deviation 1.49	-1.27 units on a scale Standard Deviation 1.56	-1.63 units on a scale Standard Deviation 1.76
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 6	-0.92 units on a scale Standard Deviation 1.25	-1.01 units on a scale Standard Deviation 1.32	-1.13 units on a scale Standard Deviation 1.52	-1.58 units on a scale Standard Deviation 1.73
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 7	-1.03 units on a scale Standard Deviation 1.31	-1.06 units on a scale Standard Deviation 1.40	-1.13 units on a scale Standard Deviation 1.59	-1.57 units on a scale Standard Deviation 1.72
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 8	-1.09 units on a scale Standard Deviation 1.39	-1.07 units on a scale Standard Deviation 1.49	-1.26 units on a scale Standard Deviation 1.59	-1.53 units on a scale Standard Deviation 1.79
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 10	-1.18 units on a scale Standard Deviation 1.44	-1.19 units on a scale Standard Deviation 1.56	-1.33 units on a scale Standard Deviation 1.65	-1.67 units on a scale Standard Deviation 1.83
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 11	-1.25 units on a scale Standard Deviation 1.46	-1.23 units on a scale Standard Deviation 1.57	-1.36 units on a scale Standard Deviation 1.64	-1.69 units on a scale Standard Deviation 1.80
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 12	-1.28 units on a scale Standard Deviation 1.50	-1.24 units on a scale Standard Deviation 1.60	-1.36 units on a scale Standard Deviation 1.67	-1.82 units on a scale Standard Deviation 1.84
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 13	-1.32 units on a scale Standard Deviation 1.55	-1.27 units on a scale Standard Deviation 1.63	-1.43 units on a scale Standard Deviation 1.72	-1.85 units on a scale Standard Deviation 1.93
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 14	-1.37 units on a scale Standard Deviation 1.60	-1.34 units on a scale Standard Deviation 1.74	-1.47 units on a scale Standard Deviation 1.69	-1.88 units on a scale Standard Deviation 1.88

SECONDARY outcome

Timeframe: From baseline (Week 14) to Week 66

Population: Visual analog scale was assessed in all enrolled participants.

Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome. In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity.

Outcome measures

Outcome measures
Measure	Placebo n=214 Participants Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.	DS-5565 15mg QD Participants who received an oral dose of DS-5565 15 mg every day (QD). During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week. During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks.	DS-5565 20 mg (10 mg BID) Participants who received an oral dose of DS-5565 20 mg (10 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week. During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks.	DS-5565 30 mg (15 mg BID) Participants who received an oral dose of DS-5565 30 mg (15 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week. During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks.
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 66	-10.80 units on a scale Standard Deviation 13.950	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 16	-0.90 units on a scale Standard Deviation 9.190	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 18	-4.00 units on a scale Standard Deviation 11.140	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 22	-7.00 units on a scale Standard Deviation 12.690	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 26	-6.20 units on a scale Standard Deviation 11.430	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 30	-7.20 units on a scale Standard Deviation 12.620	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 34	-7.80 units on a scale Standard Deviation 13.260	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 38	-7.30 units on a scale Standard Deviation 15.230	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 42	-8.00 units on a scale Standard Deviation 14.420	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 46	-8.10 units on a scale Standard Deviation 15.780	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 50	-7.80 units on a scale Standard Deviation 15.100	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 54	-9.20 units on a scale Standard Deviation 14.360	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 58	-8.80 units on a scale Standard Deviation 14.940	—	—	—
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain Week 62	-10.00 units on a scale Standard Deviation 15.390	—	—	—

Adverse Events

Placebo

Serious events: 11 serious events

Other events: 101 other events

Deaths: 0 deaths

DS-5565 15mg QD

Serious events: 4 serious events

Other events: 60 other events

Deaths: 0 deaths

DS-5565 20 mg (10 mg BID)

Serious events: 8 serious events

Other events: 62 other events

Deaths: 2 deaths

DS-5565 30 mg (15 mg BID)

Serious events: 11 serious events

Other events: 84 other events

Deaths: 0 deaths

DS-5565 Open-label Extension

Serious events: 24 serious events

Other events: 141 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=330 participants at risk Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.	DS-5565 15mg QD n=164 participants at risk Participants who received an oral dose of DS-5565 15 mg every day (QD). During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week. During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks.	DS-5565 20 mg (10 mg BID) n=165 participants at risk Participants who received an oral dose of DS-5565 20 mg (10 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week. During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks.	DS-5565 30 mg (15 mg BID) n=165 participants at risk Participants who received an oral dose of DS-5565 30 mg (15 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week. During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks.	DS-5565 Open-label Extension n=214 participants at risk Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.
Infections and infestations Bronchitis	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Infections and infestations Perinephric abscess	0.30% 1/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Infections and infestations Pyelonephritis acute	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Infections and infestations Subcutaneous abscess	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.30% 1/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Nervous system disorders Cerebal infarction	0.30% 1/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Nervous system disorders Lacunar infarction	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Nervous system disorders Loss of consciousness	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Eye disorders Diplopia	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Eye disorders Cataract	0.30% 1/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Eye disorders Diabetic retinopathy	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Eye disorders Glaucoma	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Eye disorders Vitreous haemorrhage	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Cardiac disorders Acute myocardial infarction	0.30% 1/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Cardiac disorders Angina pectoris	0.30% 1/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Cardiac disorders Atrioventricular block second degree	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.30% 1/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Gastrointestinal disorders Duodenal ulcer perforation	0.30% 1/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Hepatobiliary disorders Cholangitis	0.30% 1/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Skin and subcutaneous tissue disorders Diabetic foot	0.30% 1/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
General disorders Death	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
General disorders Drowning	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
General disorders Oedema	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Investigations Alanine aminotransferase increased	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Burns third degree	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Comminuted fracture	0.30% 1/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Infections and infestations Urinary tract infection	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Nervous system disorders VIIth nerve paralysis	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Eye disorders Macular oedema	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Eye disorders Retinal detachment	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Cardiac disorders Coronary artery disease	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Cardiac disorders Myocardial infarction	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Vascular disorders Peripheral arterial occlusion	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.93% 2/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Ulnar nerve injury	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.00% 0/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.47% 1/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.

Other adverse events

Other adverse events
Measure	Placebo n=330 participants at risk Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.	DS-5565 15mg QD n=164 participants at risk Participants who received an oral dose of DS-5565 15 mg every day (QD). During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week. During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks.	DS-5565 20 mg (10 mg BID) n=165 participants at risk Participants who received an oral dose of DS-5565 20 mg (10 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week. During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks.	DS-5565 30 mg (15 mg BID) n=165 participants at risk Participants who received an oral dose of DS-5565 30 mg (15 mg BID). During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week. During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks.	DS-5565 Open-label Extension n=214 participants at risk Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.
Infections and infestations Nasopharyngitis	12.7% 42/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	13.4% 22/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	14.5% 24/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	16.4% 27/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	27.1% 58/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Nervous system disorders Somnolence	3.9% 13/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	8.5% 14/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	12.1% 20/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	14.5% 24/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	9.3% 20/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Nervous system disorders Dizziness	2.1% 7/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	4.9% 8/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	8.5% 14/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	10.9% 18/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	7.5% 16/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
General disorders Oedema peripheral	1.2% 4/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	4.9% 8/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	2.4% 4/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	8.5% 14/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	11.2% 24/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Investigations Weight increased	0.61% 2/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	2.4% 4/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	3.0% 5/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	6.7% 11/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	7.9% 17/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Injury, poisoning and procedural complications Contusion	1.8% 6/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	1.2% 2/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	1.8% 3/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	5.5% 9/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	4.2% 9/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.91% 3/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	1.8% 3/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	5.6% 12/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Metabolism and nutrition disorders Hypoglycaemia	3.3% 11/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	1.2% 2/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	2.4% 4/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	5.6% 12/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Eye disorders Diabetic retinopathy	4.8% 16/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	4.3% 7/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	1.8% 3/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	3.6% 6/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	11.7% 25/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Gastrointestinal disorders Diarrhoea	1.8% 6/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	1.2% 2/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	1.2% 2/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	8.4% 18/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Gastrointestinal disorders Constipation	2.4% 8/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	1.8% 3/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	1.8% 3/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	3.0% 5/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	5.6% 12/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
Musculoskeletal and connective tissue disorders Back pain	2.1% 7/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	2.4% 4/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	2.4% 4/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	2.4% 4/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	5.1% 11/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.
General disorders Oedema	0.00% 0/330 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	1.2% 2/164 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	0.61% 1/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	1.2% 2/165 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.	6.1% 13/214 • Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months. A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo, Inc.

Phone: 1-908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place