Trial Outcomes & Findings for The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer (NCT NCT03581786)

Results Overview

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy as measured by IRC-assessed progression free survival (PFS) according to RECIST v1.1 in all patients. The definition of Progressive Disease: At least a 20% increasein the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. or the appearance of one or more new lesions is also considered progression.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

289 participants

Primary outcome timeframe

up to 2 years

Results posted on

2025-09-02

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Combine With Chemotherapy In the during-chemotherapy phase, placebo will be given before gemcitabine and cisplatin, placebo will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles. During the post-chemotherapy phase, placebo and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy In the during-chemotherapy phase, JS001 will be given before gemcitabine and cisplatin, JS001 will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles . During the post-chemotherapy phase, JS001 and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.
Overall Study STARTED	143	146
Overall Study COMPLETED	67	89
Overall Study NOT COMPLETED	76	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Combine With Chemotherapy In the during-chemotherapy phase, placebo will be given before gemcitabine and cisplatin, placebo will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles. During the post-chemotherapy phase, placebo and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy In the during-chemotherapy phase, JS001 will be given before gemcitabine and cisplatin, JS001 will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles . During the post-chemotherapy phase, JS001 and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.
Overall Study Death	67	47
Overall Study Withdrawal by Subject	2	5
Overall Study Lost to Follow-up	7	4
Overall Study reason other than specified above	0	1

Baseline Characteristics

The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy	Total n=289 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	136 Participants n=5 Participants	139 Participants n=7 Participants	275 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous	49.68 years STANDARD_DEVIATION 10.355 • n=5 Participants	45.84 years STANDARD_DEVIATION 11.26 • n=7 Participants	47.74 years STANDARD_DEVIATION 10.973 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	124 Participants n=7 Participants	240 Participants n=5 Participants
Race/Ethnicity, Customized Asian	143 Participants n=5 Participants	146 Participants n=7 Participants	289 Participants n=5 Participants
Region of Enrollment Singapore	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment China	134 participants n=5 Participants	136 participants n=7 Participants	270 participants n=5 Participants
Region of Enrollment Taiwan	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 2 years

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy as measured by IRC-assessed progression free survival (PFS) according to RECIST v1.1 in all patients. The definition of Progressive Disease: At least a 20% increasein the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. or the appearance of one or more new lesions is also considered progression.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1	8.2 months Interval 7.03 to 9.79	21.4 months Interval 11.73 to Due to insufficient number of participants with events, the upper limit of the survival curve hasn't reached 50%, there is no estimate for the upper confidence limit on the median.

SECONDARY outcome

Timeframe: The time frame of OS collected is upto about 48months.

Population: NE below means "not estimable".

Overall survival was defined as the time from randomization to death from any cause.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
OS	33.7 months Interval 27.01 to 44.19	NA months Interval 38.7 to Due to insufficient number of participants with events, median and the upper limit of the survival curve hasn't reached 50%, there is no estimate for the median and the upper confidence limit on the median.

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Investigator-assessed ORR According to RECIST v1.1	75.5 Percentage of Participants Interval 67.64 to 82.32	82.2 Percentage of Participants Interval 75.01 to 88.02

SECONDARY outcome

Timeframe: From date of response until progressive disease. Up to 2 approximately years

To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=108 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=120 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Investigator-assessed DoR According to RECIST v1.1	6.0 months Interval 5.75 to 7.16	16.0 months Interval 11.93 to 22.47

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed disease control rate (DCR) according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Investigator-assessed DCR According to RECIST v1.1	90.9 Percentage of Participants Interval 84.96 to 95.07	91.1 Percentage of Participants Interval 85.26 to 95.17

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Investigator-assessed PFS According to RECIST v1.1	8.1 months Interval 7.1 to 8.61	17.3 months Interval 13.34 to 23.26

SECONDARY outcome

Timeframe: up to approximately 1years

To evaluate the PFS rate at 1 year in each treatment arm by investigator

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Investigator-assessed PFS Rate at 1 Year	26.2 Percentage of Participants Interval 18.96 to 33.99	61.4 Percentage of Participants Interval 52.28 to 69.27

SECONDARY outcome

Timeframe: Up to approximately 1 years

To evaluate the OS rate at 1 year in each treatment arm

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
OS Rate at 1 Year	87.1 Percentage of Participants Interval 80.36 to 91.69	90.9 Percentage of Participants Interval 84.87 to 94.62

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H\&N35

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
IRC-assessed ORR According to RECIST v1.1	67.1 Percentage of Participants Interval 58.79 to 74.75	78.8 Percentage of Participants Interval 71.24 to 85.09

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed duration of response (DoR) according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=96 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=115 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
IRC-assessed DoR According to RECIST v1.1	6.0 months Interval 5.55 to 8.25	18.0 months Interval 10.51 to Due to insufficient number of participants with events, the upper limit of the survival curve has not reached 50%, there is no estimate for the upper confidence limit on the median.

SECONDARY outcome

Timeframe: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed disease control rate (DCR) according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
IRC-assessed DCR According to RECIST v1.1	80.4 Percentage of Participants Interval 72.96 to 86.58	88.4 Percentage of Participants Interval 82.01 to 93.07

SECONDARY outcome

Timeframe: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years

Incidence of adverse events(AE) as assessed by CTCAE version 5.0

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Number of Participants Experiencing an Adverse Event(AE)	143 Participants	146 Participants

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

Population: ADA testing only was applicable for Toripalimab group

To evaluate the incidence of ADAs against JS001

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Anti-drug Antibody(ADA)	0 Participants	10 Participants

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
PFS IRC-assessed Per irRECIST	8.3 months Interval 7.06 to 9.89	21.6 months Interval 13.17 to Due to insufficient number of participants with events, the upper limit of the survival curve has not reached 50%, there is no estimate for the upper confidence limit on the median.

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
ORR IRC-assessed Per irRECIST	67.8 Percentage of Participants Interval 59.51 to 75.39	78.8 Percentage of Participants Interval 71.24 to 85.09

SECONDARY outcome

Timeframe: From date of response until progressive disease. Up to 2 approximately years

Population: NE below means "not estimable"

To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=97 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=115 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
DoR IRC-assessed Per irRECIST	5.9 months Interval 5.55 to 8.25	20.1 months Interval 14.09 to Due to insufficient number of participants with events, the upper limit of the survival curve has not reached 50%, there is no estimate for the upper confidence limit on the median.

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
DCR IRC-assessed Per irRECIST	81.8 Percentage of Participants Interval 74.51 to 87.77	88.4 Percentage of Participants Interval 82.01 to 93.07

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

To evaluate the PFS rate at 2 years in each treatment arm by investigator

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Investigator-assessed PFS Rate at 2 Years	15.4 Percentage of Participants Interval 9.59 to 22.53	37.0 Percentage of Participants Interval 26.53 to 47.43

SECONDARY outcome

Timeframe: Up to approximately 2 years

To evaluate the OS rate at 2 years in each treatment arm

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
OS Rate at 2 Years	65.1 Percentage of Participants Interval 56.5 to 72.44	78.0 Percentage of Participants Interval 70.18 to 83.97

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
PFS Investigator-assessed Per irRECIST	8.1 months Interval 7.06 to 8.61	17.3 months Interval 13.34 to 23.26

SECONDARY outcome

Timeframe: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years

To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
ORR Investigator-assessed Per irRECIST	75.5 Percentage of Participants Interval 67.64 to 82.32	82.2 Percentage of Participants Interval 75.01 to 88.02

SECONDARY outcome

Timeframe: From date of response until progressive disease. Up to 2 approximately years

To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=108 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=120 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
DoR Investigator-assessed Per irRECIST	5.9 months Interval 5.72 to 7.16	16.0 months Interval 11.93 to 22.47

SECONDARY outcome

Timeframe: Up to approximately 42 months

To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

Outcome measures

Outcome measures
Measure	Placebo Combine With Chemotherapy n=143 Participants Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 Participants TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
DCR Investigator-assessed Per irRECIST	90.9 Percentage of Participants Interval 84.96 to 95.07	91.1 Percentage of Participants Interval 85.26 to 95.17

Adverse Events

Placebo Combine With Chemotherapy

Serious events: 62 serious events

Other events: 143 other events

Deaths: 67 deaths

TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy

Serious events: 64 serious events

Other events: 146 other events

Deaths: 47 deaths

Serious adverse events

Other adverse events

Additional Information

Xiaojun Wang

Shanghai Junshi Bioscience Co., Ltd.

Phone: 86-021-50796193

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo Combine With Chemotherapy n=143 participants at risk Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 participants at risk TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Blood and lymphatic system disorders Blood and lymphatic system disorders	27.3% 39/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	26.7% 39/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Infections and infestations Infections and infestations	7.0% 10/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	13.0% 19/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Metabolism and nutrition disorders Metabolism and nutrition disorders	3.5% 5/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	4.8% 7/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
General disorders General disorders and administration site	3.5% 5/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	3.4% 5/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Gastrointestinal disorders Gastrointestinal disorders	1.4% 2/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	4.1% 6/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Hepatobiliary disorders Hepatobiliary disorders	2.8% 4/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	3.4% 5/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	2.1% 3/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	2.7% 4/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue	1.4% 2/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	2.7% 4/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Investigations Investigations	2.1% 3/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	0.68% 1/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Nervous system disorders Nervous system disorders	2.1% 3/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	2.7% 4/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Cardiac disorders Cardiac disorders	0.70% 1/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	1.4% 2/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	0.00% 0/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	2.1% 3/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Ear and labyrinth disorders Ear and labyrinth disorders	0.00% 0/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	0.68% 1/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Renal and urinary disorders Renal and urinary disorders	0.70% 1/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	2.1% 3/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Endocrine disorders Endocrine disorders	0.00% 0/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	1.4% 2/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Psychiatric disorders psychiatric disorders	1.4% 2/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	0.00% 0/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Eye disorders eye disorders	0.00% 0/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	0.68% 1/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	0.00% 0/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	0.68% 1/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Reproductive system and breast disorders Reproductive system and breast disorders	0.70% 1/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	0.00% 0/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.

Measure	Placebo Combine With Chemotherapy n=143 participants at risk Placebos: placebo combine with chemotherapy	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy n=146 participants at risk TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Blood and lymphatic system disorders Blood and lymphatic system disorders	99.3% 142/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	97.9% 143/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Gastrointestinal disorders Gastrointestinal disorders	96.5% 138/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	92.5% 135/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Metabolism and nutrition disorders Metabolism and nutrition disorders	82.5% 118/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	79.5% 116/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Investigations Investigations	63.6% 91/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	60.3% 88/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
General disorders General disorders and administration site conditions	63.6% 91/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	61.0% 89/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Nervous system disorders Nervous system disorders	54.5% 78/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	57.5% 84/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders Cough	49.7% 71/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	47.3% 69/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	35.0% 50/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	46.6% 68/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Infections and infestations Infections and infestations	26.6% 38/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	42.5% 62/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	28.0% 40/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	29.5% 43/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Endocrine disorders Endocrine disorders	18.9% 27/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	36.3% 53/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Psychiatric disorders Psychiatric disorders	21.0% 30/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	25.3% 37/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Ear and labyrinth disorders Ear and labyrinth disorders	12.6% 18/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	15.1% 22/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Renal and urinary disorders Renal and urinary disorders	7.0% 10/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	12.3% 18/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Hepatobiliary disorders Hepatobiliary disorders	4.9% 7/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	8.2% 12/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Eye disorders Eye disorders	4.9% 7/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	8.2% 12/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	2.1% 3/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	5.5% 8/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Vascular disorders Vascular disorders	14.7% 21/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	21.9% 32/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
Cardiac disorders Cardiac disorders	5.6% 8/143 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.	4.8% 7/146 • Up to approximately 48 months All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.