Trial Outcomes & Findings for Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors. (NCT NCT04171141)

NCT ID: NCT04171141

Last Updated: 2025-01-16

Results Overview

Hematological DLTs: * Grade 3 neutropenia lasting \>5 days * Febrile neutropenia defined as an ANC \<1.0 x 10 ̂9/L with a single temperature of \>38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour * Grade ≥3 Neutropenia with infection * Grade 3 Thrombocytopenia with Grade ≥2 (clinically significant) bleeding * any Grade 4 Thrombocytopenia * Anemia or Thrombocytopenia requiring transfusion Non Hematological DLTs: * Grade ≥3 fatigue lasting ≥7 days * for participants with liver, bone, or lung metastasis, an AST or ALT increase \>8 x ULN or ALP \>10 x ULN; * confirmed DILI meeting Hy's law criteria * Grade 3 Vomiting or Diarrhea lasting ≥3 days despite adequate treatment/other supportive care * Grade 4 Vomiting or Diarrhea * Grade ≥3 CRS regardless of duration * Grade ≥3 QTcF prolongation irrespective of duration * any death not clearly due to underlying disease or extraneous causes Clinically important/persistent toxicities were DLTs reviewed by investigators and sponsor.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 79 participants
• Primary outcome timeframe: 28 Days
• Results posted on: 2025-01-16

Participant Flow

Dose Expansion Phase (Part 2) of the study was not conducted due to the study termination. Study termination was due to a strategic decision but not any safety concerns or requests from any regulatory authorities.

Participant milestones

Measure	Part 1A PF-07062119 45 µg Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Overall Study STARTED	2	3	6	9	2	10	6	6	8	4	4	3	4	4	5	3
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	2	3	6	9	2	10	6	6	8	4	4	3	4	4	5	3

Reasons for withdrawal

Measure	Part 1A PF-07062119 45 µg Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Overall Study Adverse Event	0	0	2	0	0	0	0	0	0	0	0	0	0	2	0	0
Overall Study Physician Decision	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1
Overall Study Progressive disease	2	3	4	7	1	8	4	6	7	3	4	3	4	2	4	1
Overall Study Withdrawal by Subject	0	0	0	1	0	0	1	0	0	1	0	0	0	0	0	0
Overall Study Global deterioration of health status	0	0	0	1	0	2	1	0	1	0	0	0	0	0	1	1

Baseline Characteristics

Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.

Baseline characteristics by cohort

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via subcutaneous (SC) injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	PART 1A PF-07062119 400 µg/3700 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.	Total n=79 Participants Total of all reporting groups
Age, Continuous	64 Years STANDARD_DEVIATION 16.97 • n=5 Participants	60.7 Years STANDARD_DEVIATION 6.03 • n=7 Participants	60.8 Years STANDARD_DEVIATION 10.38 • n=5 Participants	56.9 Years STANDARD_DEVIATION 10.97 • n=4 Participants	41.0 Years STANDARD_DEVIATION 12.73 • n=21 Participants	55.9 Years STANDARD_DEVIATION 15.49 • n=8 Participants	63.3 Years STANDARD_DEVIATION 15.36 • n=8 Participants	55.2 Years STANDARD_DEVIATION 13.11 • n=24 Participants	55.5 Years STANDARD_DEVIATION 8.62 • n=42 Participants	65.0 Years STANDARD_DEVIATION 11.34 • n=42 Participants	62.3 Years STANDARD_DEVIATION 8.54 • n=42 Participants	50.3 Years STANDARD_DEVIATION 9.61 • n=42 Participants	53.3 Years STANDARD_DEVIATION 14.24 • n=36 Participants	54.3 Years STANDARD_DEVIATION 18.80 • n=36 Participants	52.2 Years STANDARD_DEVIATION 11.69 • n=24 Participants	53.3 Years STANDARD_DEVIATION 9.61 • n=135 Participants	56.9 Years STANDARD_DEVIATION 12.25 • n=136 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants	1 Participants n=36 Participants	1 Participants n=24 Participants	2 Participants n=135 Participants	30 Participants n=136 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=8 Participants	3 Participants n=8 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=36 Participants	3 Participants n=36 Participants	4 Participants n=24 Participants	1 Participants n=135 Participants	49 Participants n=136 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	0 Participants n=24 Participants	1 Participants n=135 Participants	12 Participants n=136 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=8 Participants	6 Participants n=8 Participants	5 Participants n=24 Participants	6 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=36 Participants	3 Participants n=36 Participants	5 Participants n=24 Participants	2 Participants n=135 Participants	62 Participants n=136 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	5 Participants n=136 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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants	1 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	25 Participants n=136 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	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	1 Participants n=136 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	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	3 Participants n=136 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=36 Participants	3 Participants n=36 Participants	4 Participants n=24 Participants	3 Participants n=135 Participants	46 Participants n=136 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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	4 Participants n=136 Participants

PRIMARY outcome

Timeframe: 28 Days

Population: Analysis population included all enrolled participants who had at least 1 dose of study intervention and either experienced DLT or did not have major treatment deviations during the DLT observation period.

Hematological DLTs:

• Grade 3 neutropenia lasting >5 days
• Febrile neutropenia defined as an ANC <1.0 x 10 ̂9/L with a single temperature of >38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour
• Grade ≥3 Neutropenia with infection
• Grade 3 Thrombocytopenia with Grade ≥2 (clinically significant) bleeding
• any Grade 4 Thrombocytopenia
• Anemia or Thrombocytopenia requiring transfusion

Non Hematological DLTs:

• Grade ≥3 fatigue lasting ≥7 days
• for participants with liver, bone, or lung metastasis, an AST or ALT increase >8 x ULN or ALP >10 x ULN;
• confirmed DILI meeting Hy's law criteria
• Grade 3 Vomiting or Diarrhea lasting ≥3 days despite adequate treatment/other supportive care
• Grade 4 Vomiting or Diarrhea
• Grade ≥3 CRS regardless of duration
• Grade ≥3 QTcF prolongation irrespective of duration
• any death not clearly due to underlying disease or extraneous causes Clinically important/persistent toxicities were DLTs reviewed by investigators and sponsor.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=5 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=3 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=7 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=3 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=2 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=2 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 4 Years

Population: Analysis population included all enrolled participants who received at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. AEs were documented and recorded at each visit using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs Number of Participants With All-Causality TEAEs	2 Participants	3 Participants	6 Participants	9 Participants	2 Participants	10 Participants	6 Participants	6 Participants	8 Participants	4 Participants	4 Participants	3 Participants	4 Participants	4 Participants	5 Participants	3 Participants
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs Number of Participants With All-Causality TESAEs	0 Participants	1 Participants	2 Participants	3 Participants	1 Participants	4 Participants	4 Participants	2 Participants	4 Participants	1 Participants	2 Participants	0 Participants	0 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs Number of Participants With Maximum Grade 3 or 4 TEAEs	0 Participants	1 Participants	3 Participants	4 Participants	2 Participants	6 Participants	2 Participants	3 Participants	6 Participants	3 Participants	3 Participants	1 Participants	1 Participants	4 Participants	2 Participants	1 Participants
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs Number of Participants With Maximum Grade 5 TEAEs	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 4 Years

Population: Analysis population included all enrolled participants who received at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator. AEs were documented and recorded at each visit using the NCI CTCAE version 5.0. Severe AEs were classified as Grade 3; life-threatening consequences and urgent intervention indicated were classified as Grade 4; deaths related to AEs were classified as Grade 5.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs Number of Participants With Treatment-Related TEAEs	2 Participants	3 Participants	6 Participants	9 Participants	2 Participants	10 Participants	6 Participants	6 Participants	8 Participants	4 Participants	4 Participants	3 Participants	4 Participants	4 Participants	5 Participants	3 Participants
Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs Number of Participants With Treatment-Related TESAEs	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	2 Participants	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs	0 Participants	0 Participants	1 Participants	3 Participants	2 Participants	5 Participants	0 Participants	3 Participants	4 Participants	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs Number of Participants With Treatment-Related Maximum Grade 5 TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 4 Years

Population: Analysis population included all enrolled participants who received at least 1 dose of study intervention.

The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the CRF. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities Grade 3 Lymphocyte count decreased	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	3 Participants	0 Participants	3 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities Grade 4 Lymphocyte count decreased	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities Grade 3 Anemia	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities Grade 3 Hemoglobin increased	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities Grade 3 White blood cell decreased	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities Grade 4 Platelet count decreased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 4 Years

Population: Analysis population included all enrolled participants who received at least 1 dose of study intervention.

The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the case report form (CRF). Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 3 Blood bilirubin increased	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 4 Aspartate aminotransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 3 Alanine aminotransferase increased	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 3 Alkaline phosphatase increased	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 3 Aspartate aminotransferase increased	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 4 Blood bilirubin increased	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 3 Creatinine increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 3 Hypermagnesemia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 3 Hypokalemia	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 4 Hypomagnesemia	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 3 Hyponatremia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 3 Lipase increased	0 Participants	0 Participants	0 Participants	3 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 4 Lipase increased	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 3 Serum amylase increased	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities Grade 4 Serum amylase increased	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1

Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.

Cmax was observed directly from data.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=10 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=6 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=8 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=4 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=3 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts Cycle 1 Day 1	27.75 ng/mL Geometric Coefficient of Variation 52	23.66 ng/mL Geometric Coefficient of Variation 33	30.98 ng/mL Geometric Coefficient of Variation 31	37.79 ng/mL Geometric Coefficient of Variation 53	36.04 ng/mL Geometric Coefficient of Variation 16	38.10 ng/mL Geometric Coefficient of Variation 16	29.32 ng/mL Geometric Coefficient of Variation 44	37.59 ng/mL Geometric Coefficient of Variation 31	37.37 ng/mL Geometric Coefficient of Variation 13	—	—	—	—	—	—	—
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts Cycle 1 Day 15	67.03 ng/mL Geometric Coefficient of Variation 35	67.34 ng/mL Geometric Coefficient of Variation 53	142.1 ng/mL Geometric Coefficient of Variation 54	224.2 ng/mL Geometric Coefficient of Variation 59	333.9 ng/mL Geometric Coefficient of Variation 30	427.5 ng/mL Geometric Coefficient of Variation 6	76.74 ng/mL Geometric Coefficient of Variation 31	92.64 ng/mL Geometric Coefficient of Variation 60	143.2 ng/mL Geometric Coefficient of Variation 15	—	—	—	—	—	—	—
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts Cycle 4 Day 1	145 ng/mL Geometric Coefficient of Variation NA One participant with evaluable Cmax result at this visit, so the individual value is presented.	190 ng/mL Geometric Coefficient of Variation NA One participant with evaluable Cmax result at this visit, so the individual value is presented.	—	598.1 ng/mL Geometric Coefficient of Variation 16	744.5 ng/mL Geometric Coefficient of Variation NA Two participants with evaluable Cmax results at this visit (738 and 751 ng/mL), so the geometric %CV was NA.	987 ng/mL Geometric Coefficient of Variation NA One participant with evaluable Cmax result at this visit, so the individual value is presented.	26.45 ng/mL Geometric Coefficient of Variation 13966	—	326.26 ng/mL Geometric Coefficient of Variation NA Two participants with evaluable Cmax results at this visit (299 and 356 ng/mL), so the geometric %CV was NA.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1

Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.

Cmax was observed directly from data.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=3 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=5 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts Cycle 1 Day 1	2.96 ng/mL Geometric Coefficient of Variation NA Two participants with evaluable Cmax results at this visit (2.93 and 3.00 ng/mL), so the geometric %CV was NA.	9.032 ng/mL Geometric Coefficient of Variation 10	43.67 ng/mL Geometric Coefficient of Variation 40	66.75 ng/mL Geometric Coefficient of Variation 39	132.2 ng/mL Geometric Coefficient of Variation NA Two participants with evaluable Cmax results at this visit (115 and 152 ng/mL), so the geometric %CV was NA.	23.35 ng/mL Geometric Coefficient of Variation 16	55.96 ng/mL Geometric Coefficient of Variation 29	—	—	—	—	—	—	—	—	—
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts Cycle 4 Day 1	—	—	110 ng/mL Geometric Coefficient of Variation NA One participant with evaluable Cmax result at this visit, so the individual value is presented.	164.92 ng/mL Geometric Coefficient of Variation NA Two participants with evaluable Cmax results at this visit (136 and 200 ng/mL), so the geometric %CV was NA.	—	62.9 ng/mL Geometric Coefficient of Variation NA One participant with evaluable Cmax result at this visit, so the individual value is presented.	193 ng/mL Geometric Coefficient of Variation NA One participant with evaluable Cmax result at this visit, so the individual value is presented.	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1

Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.

Tmax was time at which Cmax occurred which was observed directly from data as time of first occurrence.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=10 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=6 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=8 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=4 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=3 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts Cycle 1 Day 1	167 Hour Interval 152.0 to 360.0	222 Hour Interval 141.0 to 335.0	178 Hour Interval 144.0 to 332.0	165 Hour Interval 143.0 to 386.0	167 Hour Interval 164.0 to 187.0	167 Hour Interval 144.0 to 192.0	167 Hour Interval 23.4 to 330.0	167 Hour Interval 164.0 to 190.0	166 Hour Interval 164.0 to 190.0	—	—	—	—	—	—	—
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts Cycle 1 Day 15	162 Hour Interval 94.0 to 187.0	129 Hour Interval 21.7 to 214.0	152 Hour Interval 88.1 to 192.0	151 Hour Interval 89.6 to 192.0	128 Hour Interval 8.88 to 168.0	132 Hour Interval 72.4 to 171.0	111 Hour Interval 94.7 to 167.0	167 Hour Interval 23.9 to 170.0	73.2 Hour Interval 46.2 to 163.0	—	—	—	—	—	—	—
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts Cycle 4 Day 1	19.0 Hour Interval 19.0 to 19.0	21.8 Hour Interval 21.8 to 21.8	—	83.5 Hour Interval 25.3 to 209.0	131 Hour Interval 118.0 to 144.0	26.5 Hour Interval 26.5 to 26.5	94.5 Hour Interval 18.2 to 140.0	—	104.2 Hour Interval 67.4 to 141.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1

Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.

Tmax was time at which Cmax occurred which was observed directly from data as time of first occurrence.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=3 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=5 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts Cycle 1 Day 1	173.11 Hour Interval 8.22 to 338.0	186 Hour Interval 94.7 to 191.0	93.3 Hour Interval 90.7 to 387.0	96.8 Hour Interval 26.0 to 192.0	35.85 Hour Interval 23.7 to 48.0	170 Hour Interval 96.5 to 187.0	94.0 Hour Interval 46.2 to 383.0	—	—	—	—	—	—	—	—	—
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts Cycle 4 Day 1	—	—	95.4 Hour Interval 95.4 to 95.4	95.5 Hour Interval 24.0 to 167.0	—	96.2 Hour Interval 96.2 to 96.2	23.4 Hour Interval 23.4 to 23.4	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1

Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.

AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, determined using linear/Log trapezoidal method.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=10 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=6 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=8 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=4 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=3 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts Cycle 1 Day 1	6527 ng•hour/mL Geometric Coefficient of Variation 38	5612 ng•hour/mL Geometric Coefficient of Variation 43	7864 ng•hour/mL Geometric Coefficient of Variation 42	9712 ng•hour/mL Geometric Coefficient of Variation 52	9169 ng•hour/mL Geometric Coefficient of Variation 14	10030 ng•hour/mL Geometric Coefficient of Variation 19	8387 ng•hour/mL Geometric Coefficient of Variation 37	9233 ng•hour/mL Geometric Coefficient of Variation 37	8887 ng•hour/mL Geometric Coefficient of Variation 13	—	—	—	—	—	—	—
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts Cycle 4 Day 1	42300 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUCtau measurement at this visit.	60200 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUCtau measurement at this visit.	—	168000 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUCtau measurement at this visit.	210000 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUCtau measurement at this visit.	304000 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUCtau measurement at this visit.	32500 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUCtau measurement at this visit.	—	89600 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUCtau measurement at this visit.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1

Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.

AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, determined using linear/Log trapezoidal method.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=3 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=5 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts Cycle 1 Day 1	802.577 ng•hour/mL Geometric Coefficient of Variation NA Two participants with evaluable AUCtau results at this visit (765 and 842 ng•hour/mL), so the geometric %CV was NA.	2618 ng•hour/mL Geometric Coefficient of Variation 8	12060 ng•hour/mL Geometric Coefficient of Variation 43	19120 ng•hour/mL Geometric Coefficient of Variation 35	NA ng•hour/mL Geometric Coefficient of Variation NA No participant had evaluable AUCtau result at this visit.	6346.2 ng•hour/mL Geometric Coefficient of Variation NA Two participants with evaluable AUCtau results at this visit (5170 and 7790 ng•hour/mL), so the geometric %CV was NA.	14810 ng•hour/mL Geometric Coefficient of Variation 30	—	—	—	—	—	—	—	—	—
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts Cycle 4 Day 1	—	—	32400 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUCtau measurement at this visit.	42300 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUCtau measurement at this visit.	—	17100 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUCtau measurement at this visit.	58200 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUCtau measurement at this visit.	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1

Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.

AUC168 was area under the serum concentration-time profile from Day 1 to Day 7 (168 hours) determined using linear/Log trapezoidal method.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=10 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=6 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=8 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=4 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=3 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts Cycle 1 Day 1	2994 ng•hour/mL Geometric Coefficient of Variation 51	2221 ng•hour/mL Geometric Coefficient of Variation 57	3046 ng•hour/mL Geometric Coefficient of Variation 53	4213 ng•hour/mL Geometric Coefficient of Variation 61	4030 ng•hour/mL Geometric Coefficient of Variation 26	4179 ng•hour/mL Geometric Coefficient of Variation 31	3814 ng•hour/mL Geometric Coefficient of Variation 33	4277 ng•hour/mL Geometric Coefficient of Variation 48	3649 ng•hour/mL Geometric Coefficient of Variation 20	—	—	—	—	—	—	—
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts Cycle 1 Day 15	8971 ng•hour/mL Geometric Coefficient of Variation 38	10570 ng•hour/mL Geometric Coefficient of Variation 31	15660 ng•hour/mL Geometric Coefficient of Variation 66	26700 ng•hour/mL Geometric Coefficient of Variation 68	38220 ng•hour/mL Geometric Coefficient of Variation 17	56500 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUC168 measurement at this visit.	10950 ng•hour/mL Geometric Coefficient of Variation 42	15540.785 ng•hour/mL Geometric Coefficient of Variation NA Two participants with evaluable AUC168 results at this visit (9980 and 24200 ng•hour/mL), so the geometric %CV was NA.	18127.33 ng•hour/mL Geometric Coefficient of Variation NA Two participants with evaluable AUC168 results at this visit (15500 and 21200 ng•hour/mL), so the geometric %CV was NA.	—	—	—	—	—	—	—
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts Cycle 4 Day 1	22800 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUC168 measurement at this visit.	31200 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUC168 measurement at this visit.	—	95210 ng•hour/mL Geometric Coefficient of Variation 17	117000 ng•hour/mL Geometric Coefficient of Variation NA Two participants with evaluable AUC168 results at this visit (117000 and 117000 ng•hour/mL), so the geometric %CV was NA.	158000 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUC168 measurement at this visit.	24754.80 ng•hour/mL Geometric Coefficient of Variation NA Two participants with evaluable AUC168 results at this visit (16000 and 38300 ng•hour/mL), so the geometric %CV was NA.	—	50516.83 ng•hour/mL Geometric Coefficient of Variation NA Two participants with evaluable AUC168 results at this visit (47700 and 53500 ng•hour/mL), so the geometric %CV was NA.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1

Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.

AUC168 was area under the serum concentration-time profile from Day 1 to Day 7 (168 hours) determined using linear/Log trapezoidal method.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=3 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=5 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts Cycle 1 Day 1	340.04 ng•hour/mL Geometric Coefficient of Variation NA Two participants with evaluable AUC168 results at this visit (298 and 388 ng•hour/mL), so the geometric %CV was NA.	1209 ng•hour/mL Geometric Coefficient of Variation 5	5564 ng•hour/mL Geometric Coefficient of Variation 56	9041 ng•hour/mL Geometric Coefficient of Variation 39	16500 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUC168 measurement at this visit.	2684 ng•hour/mL Geometric Coefficient of Variation 21	7133 ng•hour/mL Geometric Coefficient of Variation 40	—	—	—	—	—	—	—	—	—
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts Cycle 4 Day 1	—	—	17400 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUC168 measurement at this visit.	20700 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUC168 measurement at this visit.	—	9830 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUC168 measurement at this visit.	30900 ng•hour/mL Geometric Coefficient of Variation NA There was 1 evaluable AUC168 measurement at this visit.	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 15, Cycle 2 Days 1 and 15, Cycle 3 Days 1 and 15, Cycle 4 Days 1 and 15, Cycle 5 Day 1, Cycle 8 Day 1 and Cycle 11 Day 1

Population: Analysis population included all enrolled participants who were treated and had at least 1 analyte concentration.

PF-07062119 pre-dose trough concentrations were the serum PF-07062119 concentrations assessed at 0 min of Day 1 and Day 15 in each Cycle.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 Cycle 8 Day 1	—	—	—	—	—	—	—	—	517.5 ng/mL Interval 421.0 to 614.0	—	—	—	—	—	179.0 ng/mL Interval 179.0 to 179.0	125.0 ng/mL Interval 0.0 to 250.0
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 Cycle 1 Day 15	2.850 ng/mL Interval 2.77 to 2.93	8.140 ng/mL Interval 6.85 to 8.54	39.40 ng/mL Interval 31.7 to 48.1	56.95 ng/mL Interval 34.6 to 84.5	—	19.80 ng/mL Interval 12.9 to 42.0	22.55 ng/mL Interval 7.7 to 26.7	26.25 ng/mL Interval 19.5 to 36.0	25.30 ng/mL Interval 13.7 to 46.1	24.40 ng/mL Interval 19.8 to 29.4	30.40 ng/mL Interval 28.9 to 35.7	16.60 ng/mL Interval 14.7 to 19.5	29.80 ng/mL Interval 15.5 to 34.4	22.3 ng/mL Interval 20.0 to 25.5	44.20 ng/mL Interval 33.8 to 58.6	26.30 ng/mL Interval 21.2 to 26.6
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 Cycle 2 Day 1	3.265 ng/mL Interval 2.24 to 4.29	11.00 ng/mL Interval 10.8 to 12.1	68.50 ng/mL Interval 59.9 to 78.9	74.45 ng/mL Interval 30.3 to 113.0	47.40 ng/mL Interval 28.6 to 66.2	74.10 ng/mL Interval 48.3 to 84.4	69.80 ng/mL Interval 52.7 to 79.7	126.0 ng/mL Interval 65.4 to 226.0	176.5 ng/mL Interval 135.0 to 325.0	263.5 ng/mL Interval 230.0 to 297.0	242.0 ng/mL Interval 50.4 to 363.0	27.95 ng/mL Interval 25.3 to 30.6	57.70 ng/mL Interval 40.0 to 79.3	87.00 ng/mL Interval 86.6 to 87.4	63.25 ng/mL Interval 45.2 to 86.6	101.0 ng/mL Interval 92.1 to 109.0
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 Cycle 2 Day 15	5.25 ng/mL Interval 5.25 to 5.25	14.5 ng/mL Interval 14.5 to 14.5	74.45 ng/mL Interval 71.7 to 79.0	91.45 ng/mL Interval 37.9 to 106.0	111.0 ng/mL Interval 111.0 to 111.0	94.40 ng/mL Interval 50.8 to 120.0	90.50 ng/mL Interval 90.5 to 90.5	100.0 ng/mL Interval 61.3 to 239.0	322.0 ng/mL Interval 221.0 to 427.0	432.0 ng/mL Interval 420.0 to 444.0	358.0 ng/mL Interval 358.0 to 358.0	35.6 ng/mL Interval 30.8 to 40.4	69.35 ng/mL Interval 26.1 to 129.0	54.80 ng/mL Interval 2.6 to 107.0	92.45 ng/mL Interval 81.0 to 125.0	153.0 ng/mL Interval 145.0 to 164.0
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 Cycle 3 Day 1	—	20.6 ng/mL Interval 20.6 to 20.6	80.2 ng/mL Interval 80.2 to 80.2	107.0 ng/mL Interval 101.0 to 110.0	129.0 ng/mL Interval 129.0 to 129.0	104.0 ng/mL Interval 104.0 to 104.0	110.0 ng/mL Interval 110.0 to 110.0	188.5 ng/mL Interval 0.0 to 377.0	414.0 ng/mL Interval 297.0 to 502.0	497.0 ng/mL Interval 489.0 to 505.0	528.0 ng/mL Interval 528.0 to 528.0	40.80 ng/mL Interval 40.8 to 40.8	72.10 ng/mL Interval 3.58 to 149.0	—	110.0 ng/mL Interval 63.0 to 132.0	181.5 ng/mL Interval 162.0 to 201.0
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 Cycle 3 Day 15	—	21.9 ng/mL Interval 21.9 to 21.9	82.1 ng/mL Interval 82.1 to 82.1	114.5 ng/mL Interval 105.0 to 124.0	76.90 ng/mL Interval 76.9 to 76.9	128.0 ng/mL Interval 128.0 to 128.0	130.0 ng/mL Interval 130.0 to 130.0	—	453.0 ng/mL Interval 312.0 to 517.0	542.5 ng/mL Interval 530.0 to 555.0	559.0 ng/mL Interval 559.0 to 559.0	36.40 ng/mL Interval 36.4 to 36.4	77.50 ng/mL Interval 0.0 to 189.0	—	150.5 ng/mL Interval 146.0 to 155.0	225.5 ng/mL Interval 204.0 to 247.0
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 Cycle 4 Day 1	—	—	74.9 ng/mL Interval 74.9 to 74.9	128.0 ng/mL Interval 113.0 to 143.0	133 ng/mL Interval 133.0 to 133.0	125.0 ng/mL Interval 125.0 to 125.0	162.0 ng/mL Interval 162.0 to 162.0	—	431.5 ng/mL Interval 377.0 to 541.0	528.5 ng/mL Interval 499.0 to 558.0	706.0 ng/mL Interval 706.0 to 706.0	37.20 ng/mL Interval 37.2 to 37.2	75.80 ng/mL Interval 0.0 to 205.0	—	141.0 ng/mL Interval 141.0 to 141.0	245.5 ng/mL Interval 216.0 to 275.0
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 Cycle 4 Day 15	—	—	77.8 ng/mL Interval 77.8 to 77.8	122 ng/mL Interval 122.0 to 122.0	112 ng/mL Interval 112.0 to 112.0	108.0 ng/mL Interval 108.0 to 108.0	161.0 ng/mL Interval 161.0 to 161.0	—	429.5 ng/mL Interval 380.0 to 479.0	517.0 ng/mL Interval 512.0 to 522.0	795.0 ng/mL Interval 795.0 to 795.0	34.6 ng/mL Interval 34.6 to 34.6	94.40 ng/mL Interval 0.0 to 194.0	—	149.0 ng/mL Interval 149.0 to 149.0	226.0 ng/mL Interval 226.0 to 226.0
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 Cycle 5 Day 1	—	—	49.7 ng/mL Interval 49.7 to 49.7	117 ng/mL Interval 117.0 to 117.0	—	121.0 ng/mL Interval 121.0 to 121.0	—	—	357.0 ng/mL Interval 192.0 to 522.0	—	—	—	94.00 ng/mL Interval 0.0 to 180.0	—	147.0 ng/mL Interval 147.0 to 147.0	217.5 ng/mL Interval 189.0 to 246.0
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 Cycle 11 Day 1	—	—	—	—	—	—	—	—	636.0 ng/mL Interval 636.0 to 636.0	—	—	—	—	—	189.0 ng/mL Interval 189.0 to 189.0	98.50 ng/mL Interval 0.0 to 197.0

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5

Population: Number of participants analyzed included all enrolled participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants with ≥1 post-treatment ADA result.

Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-07062119. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for ADA against PF-07062119 were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc.). Participants with an unresolved AE possibly related to ADA were asked to return to the clinic for ADA and drug concentration assessments at approximately 3 month intervals until the AE or its sequelae resolved or stabilized at a level acceptable to the investigator and sponsor up to a maximum of 9 months.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 Treatment-Induced	0 Percentage	0 Percentage	16.7 Percentage	11.1 Percentage	0 Percentage	0 Percentage	0 Percentage	16.7 Percentage	0 Percentage	25.0 Percentage	25.0 Percentage	0 Percentage	25.0 Percentage	33.3 Percentage	20.0 Percentage	66.7 Percentage
Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 Treatment-Boosted	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	25.0 Percentage	0 Percentage	0 Percentage	0 Percentage

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and End of Treatment

Population: Number of participants analyzed included all participants who had ≥1 post-treatment ADA result. Number analyzed refers to number of participants with ADA-positive samples (titer ≥70).

Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-07062119. ADA titers of participants with positive PF-07062119 ADA (titer ≥70) are summarized.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=9 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Titers of ADA Against PF-07062119 Cycle 11 Day 1	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	120976 titers Interval 206.0 to 241746.0
Titers of ADA Against PF-07062119 Cycle 14 Day 1	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	351572 titers Interval 351572.0 to 351572.0
Titers of ADA Against PF-07062119 Cycle 1 Day 1	—	—	—	—	—	—	—	—	—	326 titers Interval 326.0 to 326.0	—	—	121 titers Interval 121.0 to 121.0	—	—	—
Titers of ADA Against PF-07062119 Cycle 1 Day 15	—	—	—	—	—	—	—	—	—	257 titers Interval 257.0 to 257.0	—	—	540 titers Interval 540.0 to 540.0	—	—	—
Titers of ADA Against PF-07062119 Cycle 2 Day 1	—	—	—	197 titers Interval 197.0 to 197.0	—	—	—	—	—	—	544 titers Interval 544.0 to 544.0	—	427 titers Interval 427.0 to 427.0	—	—	—
Titers of ADA Against PF-07062119 Cycle 3 Day 1	—	—	—	—	—	—	—	34295 titers Interval 34295.0 to 34295.0	—	—	—	—	1063 titers Interval 1063.0 to 1063.0	—	—	—
Titers of ADA Against PF-07062119 Cycle 4 Day 1	—	—	—	—	—	—	—	439158 titers Interval 439158.0 to 439158.0	—	—	—	—	16761 titers Interval 16761.0 to 16761.0	—	—	—
Titers of ADA Against PF-07062119 Cycle 5 Day 1	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	70 titers Interval 70.0 to 70.0
Titers of ADA Against PF-07062119 Cycle 8 Day 1	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	140562 titers Interval 140562.0 to 140562.0
Titers of ADA Against PF-07062119 Cycle 17 Day 1	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	155181 titers Interval 155181.0 to 155181.0
Titers of ADA Against PF-07062119 End of Treatment	—	—	4291 titers Interval 4291.0 to 4291.0	—	—	—	—	—	—	392 titers Interval 392.0 to 392.0	134678 titers Interval 134678.0 to 134678.0	—	—	2413 titers Interval 2413.0 to 2413.0	197 titers Interval 197.0 to 197.0	344 titers Interval 344.0 to 344.0

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5

Population: Number of participants analyzed included all enrolled participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants with ≥1 post-treatment NAb result.

Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of NAb against PF-07062119. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and will be drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for NAb against PF-07062119 were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc). An NAb sample was defined as positive when NAb titer was ≥2.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 Treatment-Induced	0 Percentage	0 Percentage	16.7 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	16.7 Percentage	0 Percentage	25.0 Percentage	25.0 Percentage	0 Percentage	25.0 Percentage	33.3 Percentage	0 Percentage	66.7 Percentage
Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 Treatment-Boosted	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Day 15, Cycle 2 Day 1 and Day 15, Cycle 3 Day 1 and Day 15, Cycle 4 Day 15, Cycle 5 Day 15 and End of Treatment

Population: Analysis population included all participants who had ≥1 post-treatment ADA result.

Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-06801591. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for ADA against PF-06801591 in Part 1B were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc). Participants with an unresolved AE possibly related to ADA were asked to return to the clinic for ADA and drug concentration assessments at approximately 3 month intervals until the AE or its sequelae resolved or stabilized at a level acceptable to the investigator and sponsor up to a maximum of 9 months. A participant was PF-06801591 ADA positive when ADA titer was ≥99.

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=3 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=4 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=1 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Incidence of ADA Positive Against PF-06801591	0 Percentage	0 Percentage	0 Percentage	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Baseline was defined as the time closest to, but prior to, the start of study drug administration in the first cycle), Cycle 3 Day 1

Population: Number of participants analyzed included all enrolled participants with at least 1 of the biomarkers evaluated at pre and/or post dose. Number analyzed refers to number of participants with non-missing test.

Tumor biospecimens from archival and/de novo biopsies were used to analyze candidate nucleic acid and protein and cellular biomarkers for their ability to inform those participants who were most likely to benefit from treatment with the study interventions. De novo tumor biopsies obtained during therapy and upon disease progression could be used to help confirm pharmacodynamic effects of treatment and investigate potential acquired mechanisms of resistance (ie, presence of but not limited to regulatory T-cells or myeloid derived suppressor cells and other immune suppressive cells or proteins).

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=3 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=4 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies CD3+ Cells/mm2 CT+ (cells/mm2)	—	—	—	-34.1 Percentage Interval -34.1 to -34.1	—	—	—	—	—	456.0 Percentage Interval 89.1 to 822.8	482.2 Percentage Interval 482.2 to 482.2	—	—	—	39.6 Percentage Interval 39.6 to 39.6	—
Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies PD-L1 Positive Immune Cells per Tumor Area (%)	—	—	—	1500.0 Percentage Interval 1500.0 to 1500.0	—	—	—	—	—	-20.0 Percentage Interval -20.0 to -20.0	700.0 Percentage Interval 700.0 to 700.0	—	—	—	-100.0 Percentage Interval -100.0 to -100.0	—
Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies CD8+ Cells/mm2 CT+ (cells/mm2)	—	—	—	-23.3 Percentage Interval -23.3 to -23.3	—	—	—	—	—	1848.0 Percentage Interval 290.7 to 3405.3	1378.5 Percentage Interval 1378.5 to 1378.5	—	—	—	28.4 Percentage Interval 28.4 to 28.4	—
Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies PD-L1 Tumor Cell Membrane Staining (%)	—	—	—	—	—	—	—	—	—	0 Percentage Interval 0.0 to 0.0	-100.0 Percentage Interval -100.0 to -100.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to maximum of 4 years

Population: Analysis population included all enrolled participants.

Tumor assessments included all known or suspected disease sites. Imaging included contrast enhanced chest, abdomen and pelvis CT or MRI scans; brain CT or MRI scan for participants with known or suspected brain metastases; bone scan and/or bone x rays for participants with known or suspected bone metastases. For participants with known CT contrast allergy, a non-contrast CT of the chest with contrast enhanced abdominal and pelvic MRI could be used. The same imaging technique used to characterize each identified and reported lesion at baseline was employed in the tumor assessments. Assessment of response used Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective Response was defined as complete response (CR) + partial response (PR).

Outcome measures

Measure	Part 1A PF-07062119 45 µg n=2 Participants Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 Participants Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 Participants Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 Participants Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 Participants Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=4 Participants Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 Participants Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 Participants Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 Participants Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 Participants Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Number of Participants With Confirmed Objective Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

Adverse Events

Part 1A PF-07062119 45 µg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Part 1A PF-07062119 135 µg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Part 1A PF-07062119 400 µg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 5 deaths

Part 1A PF-07062119 800 µg

Serious events: 3 serious events

Other events: 9 other events

Deaths: 8 deaths

Part 1A PF-07062119 1600 µg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Part 1A PF-07062119 400 µg/800 µg

Serious events: 4 serious events

Other events: 10 other events

Deaths: 6 deaths

Part 1A PF-07062119 400 µg/1200 µg

Serious events: 4 serious events

Other events: 5 other events

Deaths: 3 deaths

Part 1A PF-07062119 400 µg/1600 µg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

Part 1A PF-07062119 400 µg/2100 µg

Serious events: 4 serious events

Other events: 8 other events

Deaths: 1 deaths

Part 1A PF-07062119 400 µg/2800 µg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Part 1A PF-07062119 400 µg/3700 µg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming

Serious events: 0 serious events

Other events: 4 other events

Deaths: 2 deaths

Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming

Serious events: 3 serious events

Other events: 4 other events

Deaths: 2 deaths

Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Total

Serious events: 30 serious events

Other events: 78 other events

Deaths: 44 deaths

Serious adverse events

Measure	Part 1A PF-07062119 45 µg n=2 participants at risk Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 participants at risk Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 participants at risk Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 participants at risk Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 participants at risk Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=4 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 participants at risk Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 participants at risk Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 participants at risk Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 participants at risk Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 participants at risk Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.	Total n=79 participants at risk Overall Population
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Colitis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	7.6% 6/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Ileus	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Obstruction gastric	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Rectal obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Disease progression	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Pyrexia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Hepatobiliary disorders Biliary obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Hepatobiliary disorders Cholangitis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Hepatobiliary disorders Hepatic failure	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Immune system disorders Cytokine release syndrome	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	8.9% 7/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Immune system disorders Hypersensitivity	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Pneumonia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Streptococcal sepsis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Vascular disorders Hypertension	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.

Other adverse events

Measure	Part 1A PF-07062119 45 µg n=2 participants at risk Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 135 µg n=3 participants at risk Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 400 µg n=6 participants at risk Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 800 µg n=9 participants at risk Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.	Part 1A PF-07062119 1600 µg n=2 participants at risk Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).	Part 1A PF-07062119 400 µg/800 µg n=10 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1200 µg n=6 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/1600 µg n=6 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2100 µg n=8 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/2800 µg n=4 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15.	Part 1A PF-07062119 400 µg/3700 µg n=4 participants at risk Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15.	Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W n=3 participants at risk Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection.	Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 participants at risk Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming n=4 participants at risk Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.	Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W n=5 participants at risk Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight.	Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming n=3 participants at risk Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.	Total n=79 participants at risk Overall Population
Vascular disorders Vena cava thrombosis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Pyrexia	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	22.2% 2/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	37.5% 3/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 2/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.3% 16/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Ileus	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	7.6% 6/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Cardiac disorders Atrial fibrillation	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Cardiac disorders Sinus bradycardia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Cardiac disorders Tachycardia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Ear and labyrinth disorders Vertigo	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Endocrine disorders Hypothyroidism	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Eye disorders Dry eye	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Eye disorders Vision blurred	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	6.3% 5/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	15.2% 12/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Ascites	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Colitis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Constipation	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	30.0% 3/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	37.5% 3/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	75.0% 3/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	21.5% 17/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Defaecation urgency	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 4/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	88.9% 8/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 2/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	60.0% 6/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 6/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	87.5% 7/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 4/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 4/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 3/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	75.0% 3/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	60.0% 3/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 3/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	72.2% 57/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Dry mouth	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	7.6% 6/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Eructation	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Flatulence	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	6.3% 5/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Haematochezia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Lip pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 3/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	55.6% 5/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 2/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 3/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	75.0% 6/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	75.0% 3/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	60.0% 3/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 2/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	43.0% 34/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Obstruction gastric	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Proctalgia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	7.6% 6/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Proctitis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Rectal perforation	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Small intestinal stenosis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Stomatitis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 2/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 2/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	6.3% 5/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	77.8% 7/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 2/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	75.0% 6/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	75.0% 3/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	36.7% 29/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Asthenia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Axillary pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Chest discomfort	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Chills	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 3/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	13.9% 11/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Early satiety	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Fatigue	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 4/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 3/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	40.0% 4/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 3/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 4/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 2/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 3/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	38.0% 30/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Influenza like illness	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Injection site discolouration	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Injection site dryness	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Injection site erythema	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 6/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	55.6% 5/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 5/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 3/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 2/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	80.0% 4/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	46.8% 37/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Injection site pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Injection site pruritus	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 4/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 3/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	40.0% 4/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	40.0% 2/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.3% 20/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Injection site rash	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 3/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	7.6% 6/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Injection site reaction	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 3/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	37.5% 3/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	75.0% 3/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 2/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	29.1% 23/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Malaise	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Mucosal inflammation	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Non-cardiac chest pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Oedema peripheral	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	30.0% 3/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	75.0% 3/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	13.9% 11/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Pain	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	7.6% 6/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
General disorders Pre-existing condition improved	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Hepatobiliary disorders Biliary obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Hepatobiliary disorders Cholangitis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Hepatobiliary disorders Jaundice	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Immune system disorders Cytokine release syndrome	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 4/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 6/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 2/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	37.5% 3/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	60.0% 3/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	40.5% 32/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Abdominal infection	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Bacillus infection	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations COVID-19	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 2/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Conjunctivitis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Cystitis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Folliculitis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Herpes simplex reactivation	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Oral herpes	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Rectal abscess	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Skin infection	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Tooth infection	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Urinary tract infection	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Injury, poisoning and procedural complications Contusion	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Injury, poisoning and procedural complications Injection related reaction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Injury, poisoning and procedural complications Post procedural diarrhoea	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	5.1% 4/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Alanine aminotransferase increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 2/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.4% 9/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Amylase increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	22.2% 2/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	6.3% 5/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.4% 9/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.1% 8/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Blood bilirubin increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	5.1% 4/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Blood creatinine increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Blood lactate dehydrogenase increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Gamma-glutamyltransferase increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations International normalised ratio increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Lipase increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	22.2% 2/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.4% 9/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Lymphocyte count decreased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	7.6% 6/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Neutrophil count decreased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Platelet count decreased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Weight decreased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.4% 9/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations Weight increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Investigations White blood cell count increased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 3/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	40.0% 4/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 2/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.3% 20/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	22.2% 2/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	6.3% 5/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	6.3% 5/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	62.5% 5/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	19.0% 15/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypomagnesaemia	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 2/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	8.9% 7/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	5.1% 4/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	5.1% 4/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 2/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 2/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.4% 9/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Nervous system disorders Burning sensation	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Nervous system disorders Dizziness	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Nervous system disorders Dysgeusia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Nervous system disorders Headache	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 2/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	8.9% 7/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Nervous system disorders Paraesthesia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Nervous system disorders Presyncope	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Nervous system disorders Seizure	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Psychiatric disorders Anxiety	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Psychiatric disorders Depression	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Psychiatric disorders Insomnia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	3.8% 3/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Psychiatric disorders Libido decreased	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Renal and urinary disorders Haematuria	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Renal and urinary disorders Pollakiuria	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Renal and urinary disorders Proteinuria	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Reproductive system and breast disorders Breast tenderness	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Reproductive system and breast disorders Pelvic pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Reproductive system and breast disorders Scrotal oedema	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Reproductive system and breast disorders Testicular pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 2/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.7% 10/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	6.3% 5/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 2/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	5.1% 4/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	6.3% 5/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 2/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	7.6% 6/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	40.0% 2/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	6.3% 5/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	12.5% 1/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	22.2% 2/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 1/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	30.0% 3/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	37.5% 3/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 2/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	19.0% 15/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 2/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 2/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	37.5% 3/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	50.0% 2/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	21.5% 17/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	100.0% 2/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	37.5% 3/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	75.0% 3/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	19.0% 15/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	1.3% 1/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	22.2% 2/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Vascular disorders Flushing	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	16.7% 1/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	33.3% 1/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Vascular disorders Hypertension	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	25.0% 1/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	20.0% 1/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	66.7% 2/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	6.3% 5/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
Vascular disorders Hypotension	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	11.1% 1/9 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/2 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	10.0% 1/10 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/6 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/8 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/4 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/5 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	0.00% 0/3 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.	2.5% 2/79 • 4 Years Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.

Additional Information

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Results disclosure agreements

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