Trial Outcomes & Findings for Study of IBI308 With Advanced/Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-line Treatment (NCT NCT03116152)

NCT ID: NCT03116152

Last Updated: 2021-02-03

Results Overview

OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 190 participants
• Primary outcome timeframe: Through Final Analysis data cutoff date of 2-August-2019 (up to approximately 26 months)
• Results posted on: 2021-02-03

Participant Flow

253 enrolled. 190 randomized. Non-randomized reasons: 55 no longer met study criteria, 4 withdrew consent, 4 other. 181 treated (94 sintilimab, 87 chemotherapy).

Participant milestones

Measure	Sintilimab Sintilimab (IBI308) 200mg Intravenous drip every three weeks	Chemotherapy paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
Overall Study STARTED	95	95
Overall Study Treated	94	87
Overall Study COMPLETED	4	0
Overall Study NOT COMPLETED	91	95

Reasons for withdrawal

Measure	Sintilimab Sintilimab (IBI308) 200mg Intravenous drip every three weeks	Chemotherapy paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
Overall Study Disease Progression	49	47
Overall Study Death	5	2
Overall Study Adverse Event	21	7
Overall Study Protocol Violation	2	2
Overall Study Withdrawal by Subject	0	1
Overall Study Physician Decision	3	2
Overall Study other	11	34

Baseline Characteristics

Study of IBI308 With Advanced/Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-line Treatment

Baseline characteristics by cohort

Measure	Sintilimab n=95 Participants Sintilimab (IBI308) 200mg Intravenous drip every three weeks	Chemotherapy n=95 Participants paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks	Total n=190 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	74 Participants n=5 Participants	75 Participants n=7 Participants	149 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Age, Continuous	58.8 years STANDARD_DEVIATION 7.23 • n=5 Participants	59.4 years STANDARD_DEVIATION 7.06 • n=7 Participants	59.1 years STANDARD_DEVIATION 7.13 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	84 Participants n=7 Participants	172 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	95 Participants n=5 Participants	95 Participants n=7 Participants	190 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	95 participants n=5 Participants	95 participants n=7 Participants	190 participants n=5 Participants

PRIMARY outcome

Timeframe: Through Final Analysis data cutoff date of 2-August-2019 (up to approximately 26 months)

Population: The efficacy analysis population consisted of all randomized participants.

OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.

Outcome measures

Measure	Sintilimab n=95 Participants Sintilimab (IBI308) 200mg Intravenous drip every three weeks	Chemotherapy n=95 Participants paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
Overall Survival	7.23 month Interval 5.82 to 9.69	6.21 month Interval 5.39 to 7.85

SECONDARY outcome

Timeframe: Through Final Analysis data cutoff date of 2-August-2019 (up to approximately 26 months)

Population: The efficacy analysis population consisted of all randomized participants.

PFS was defined as the time from randomization to the first documented progressive disease (PD) as determined by the investigator, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Unequivocal progression of non-target leisions and the appearance of ≥1 new lesions were also considered as PD.

Outcome measures

Measure	Sintilimab n=95 Participants Sintilimab (IBI308) 200mg Intravenous drip every three weeks	Chemotherapy n=95 Participants paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
Progression-free Survival	1.58 month Interval 1.45 to 2.76	2.86 month Interval 2.56 to 3.55

SECONDARY outcome

Timeframe: Through Final Analysis data cut-off date of 2-August-2019 (up to approximately 26 months)

Population: The efficacy analysis population consisted of all randomized participants.

Objective Response Rate (ORR) was defined as the proportion of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment.

Outcome measures

Measure	Sintilimab n=95 Participants Sintilimab (IBI308) 200mg Intravenous drip every three weeks	Chemotherapy n=95 Participants paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
Objective Response Rate	12.6 Percentage of Participants Interval 6.7 to 21.0	6.3 Percentage of Participants Interval 2.4 to 13.2

SECONDARY outcome

Timeframe: Through Final Analysis data cutoff date of 2-August-2019 (up to approximately 26 months)

Population: The efficacy analysis population consisted of all randomized participants.

Duration of response (DoR) was defined as the time from the date of the first investigator-assessed response (CR or PR) to the date of subsequent investigator-assessed PD or death, whichever is earlier.

Outcome measures

Measure	Sintilimab n=95 Participants Sintilimab (IBI308) 200mg Intravenous drip every three weeks	Chemotherapy n=95 Participants paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
Duration of Response	8.28 month Interval 2.92 to 20.9	6.21 month Interval 4.57 to 8.38

Adverse Events

Sintilimab

Serious events: 41 serious events

Other events: 88 other events

Deaths: 73 deaths

Chemotherapy

Serious events: 23 serious events

Other events: 78 other events

Deaths: 82 deaths

Serious adverse events

Measure	Sintilimab n=94 participants at risk Sintilimab (IBI308) 200mg Intravenous drip every three weeks	Chemotherapy n=87 participants at risk paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
Gastrointestinal disorders Upper gastrointestinal haemorrhage	5.3% 5/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Dysphagia	2.1% 2/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Gastrointestinal haemorrhage	2.1% 2/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Gastric fistula	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Gastropleural fistula	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Ileus	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Oesophageal obstruction	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Oesophageal stenosis	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Vomiting	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Diarrhoea	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	2.3% 2/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Nausea	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Infections and infestations Pneumonia	6.4% 6/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Infections and infestations Lung infection	5.3% 5/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	4.6% 4/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Infections and infestations Biliary tract infection	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Infections and infestations Pneumonia bacterial	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Infections and infestations Pneumonia fungal	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Infections and infestations Upper respiratory tract infection	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.4% 6/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Respiratory, thoracic and mediastinal disorders Acquired tracheo-oesophageal fistula	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	2.3% 2/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Respiratory, thoracic and mediastinal disorders Cough	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiratio	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Reproductive system and breast disorders Asphyxia	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Decreased appetite	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Diabetic ketosis	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hypercalcaemia	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hyperglycaemia	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hypokalaemia	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hyponatraemia	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Malnutrition	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
General disorders Pyrexia	2.1% 2/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
General disorders Accidental death	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
General disorders Pain	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
General disorders Chest pain	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Hepatobiliary disorders Hepatic function abnormal	4.3% 4/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Injury, poisoning and procedural complications Extradural haematoma	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Injury, poisoning and procedural complications Radiation pneumonitis	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Blood and lymphatic system disorders Anaemia	2.1% 2/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	6.9% 6/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Cardiac disorders Cardiac failure	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Cardiac disorders Pericardial effusion	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Renal and urinary disorders Nephrolithiasis	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Renal and urinary disorders Renal impairment	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Renal and urinary disorders Urinary tract obstruction	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Amylase increased	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Platelet count decreased	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Neutrophil count decreased	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Nervous system disorders Cerebrovascular accident	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Nervous system disorders Transient ischaemic attack	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Vascular disorders Circulatory collapse	1.1% 1/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Vascular disorders Thrombosis	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).

Other adverse events

Measure	Sintilimab n=94 participants at risk Sintilimab (IBI308) 200mg Intravenous drip every three weeks	Chemotherapy n=87 participants at risk paclitaxel 175mg/㎡ Intravenous drip every three weeks； irinotecan 180mg/㎡ Intravenous drip every two weeks
Investigations Weight decreased	29.8% 28/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	17.2% 15/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations White blood cell count decreased	13.8% 13/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	51.7% 45/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Aspartate aminotransferase increased	12.8% 12/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	6.9% 6/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Alanine aminotransferase increased	10.6% 10/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	6.9% 6/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Amylase increased	10.6% 10/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Lymphocyte count decreased	11.7% 11/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	12.6% 11/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Neutrophil count decreased	10.6% 10/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	36.8% 32/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Gamma-glutamyltransferase increased	9.6% 9/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	3.4% 3/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Platelet count decreased	9.6% 9/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	13.8% 12/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hypoproteinaemia	24.5% 23/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	9.2% 8/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Decreased appetite	14.9% 14/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	19.5% 17/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hypoalbuminaemia	16.0% 15/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	10.3% 9/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hyponatraemia	11.7% 11/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	8.0% 7/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hypocalcaemia	10.6% 10/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hypokalaemia	9.6% 9/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	11.5% 10/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hypochloraemia	9.6% 9/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	2.3% 2/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hypercholesterolaemia	6.4% 6/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	4.6% 4/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Blood and lymphatic system disorders Anaemia	48.9% 46/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	49.4% 43/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Constipation	20.2% 19/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	16.1% 14/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Nausea	12.8% 12/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	35.6% 31/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Vomiting	12.8% 12/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	24.1% 21/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Diarrhoea	12.8% 12/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	36.8% 32/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Gastrointestinal disorders Abdominal pain	6.4% 6/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	9.2% 8/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
General disorders Asthenia	17.0% 16/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	26.4% 23/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
General disorders Pyrexia	13.8% 13/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	6.9% 6/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
General disorders Pain	5.3% 5/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	5.7% 5/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Respiratory, thoracic and mediastinal disorders Cough	24.5% 23/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	8.0% 7/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Respiratory, thoracic and mediastinal disorders Pneumonitis	10.6% 10/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Endocrine disorders Hypothyroidism	13.8% 13/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	2.3% 2/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Hepatobiliary disorders Hepatic function abnormal	10.6% 10/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	5.7% 5/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Renal and urinary disorders Proteinuria	8.5% 8/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	9.2% 8/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Infections and infestations Lung infection	7.4% 7/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	8.0% 7/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	14.9% 13/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	6.9% 6/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Blood alkaline phosphatase increased	7.4% 7/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	2.3% 2/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Blood bilirubin increased	6.4% 6/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	3.4% 3/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Lipase increased	5.3% 5/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	0.00% 0/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations Neutrophil count increased	6.4% 6/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	2.3% 2/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Investigations White blood cell count increased	6.4% 6/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	3.4% 3/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hypercalcaemia	5.3% 5/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	4.6% 4/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Metabolism and nutrition disorders Hyperglycaemia	5.3% 5/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	4.6% 4/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Musculoskeletal and connective tissue disorders Back pain	2.1% 2/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	6.9% 6/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Nervous system disorders Headache	5.3% 5/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	2.3% 2/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Nervous system disorders Hypoaesthesia	2.1% 2/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	6.9% 6/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Psychiatric disorders Insomnia	5.3% 5/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	4.6% 4/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Respiratory, thoracic and mediastinal disorders Productive cough	6.4% 6/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	1.1% 1/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).
Vascular disorders Hypertension	5.3% 5/94 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).	2.3% 2/87 • Through the Analysis data cutoff date of 2-October-2019 (up to approximately 26 months). The cutoff date for the primary efficacy analysis was 02 August 2019 when 150 OS events were actually observed. Upon the observation, the study follow-up was extended for another 2 months. The safety data was cut off as of 2-October-2019. AEs were collected till 90 days after the last dose. All-Cause Mortality assessed for all the participants who Started the study and Serious and Other (Not Including Serious) Adverse Events were assessed in all participants who received ≥1 dose of study treatment. 181 treated (94 sintilimab, 87chemotherapy).

Additional Information

Yi Bo

Innovent Biologics (Suzhou) Co., Ltd. (seal)

Phone: +8613382419112

Email: jessica.yi@innoventbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place